PROSTAR XL SUTURE-MEDIATED CLOSURE

SUTURE MEDIATED CLOSURE

This device is manufactured by ABBOTT VASCULAR.

The following problems were reported about this device:

Date Event Type Patient Problem Device Problem
2024-03-21 Injury No Clinical Signs, Symptoms or Conditions None
2024-03-20 Injury No Clinical Signs, Symptoms or Conditions None
2024-03-20 Injury No Clinical Signs, Symptoms or Conditions None
2023-06-06 Injury Obstruction/Occlusion Malposition of Device
2023-04-11 Injury No Clinical Signs, Symptoms or Conditions Product Quality Problem, Material Separation, Improper or Incorrect Procedure or Method
2022-11-17 Injury None Patient Device Interaction Problem
2022-08-01 Injury Hemorrhage/Blood Loss/Bleeding, Pain None
2019-06-19 Injury None Entrapment of Device, Failure to Fire
2019-06-06 Injury None Material Separation
2019-06-05 Injury None Material Separation
2019-05-28 Injury None Entrapment of Device, Malposition of Device
2019-05-22 Injury None Retraction Problem, Improper or Incorrect Procedure or Method
2019-05-10 Injury None Obstruction of Flow
2019-05-10 Injury None Obstruction of Flow
2019-05-01 Malfunction None Difficult to Remove
2019-04-19 Injury None Material Separation
2019-04-19 Injury None Patient Device Interaction Problem
2019-04-17 Injury None Malposition of Device
2019-04-15 Injury None Failure to Fire
2019-04-15 Injury None Failure to Fire
2019-04-15 Injury None Failure to Fire
2019-03-19 Injury None Difficult to Remove
2019-03-19 Injury None Difficult to Remove
2019-03-13 Injury None Material Separation
2019-03-13 Injury None Material Separation
2019-01-03 Injury None Patient Device Interaction Problem
2019-01-03 Injury None Failure to Fire
2018-12-10 Malfunction None Difficult or Delayed Activation, Insufficient Information
2018-12-06 Injury None Product Quality Problem
2018-11-26 Injury None Entrapment of Device, Difficult to Remove
2018-11-26 Injury None Entrapment of Device, Difficult to Remove
2018-11-26 Injury None Entrapment of Device, Difficult to Remove
2018-11-26 Injury None Entrapment of Device, Difficult to Remove
2018-11-14 Injury None Failure to Fire
2018-11-14 Injury None Failure to Fire
2018-11-07 Injury None Patient Device Interaction Problem
2018-10-02 Injury None Entrapment of Device, Failure to Fire, Difficult to Open or Close
2018-08-09 Injury None Obstruction of Flow
2018-08-09 Injury None Obstruction of Flow
2018-07-09 Injury None Failure to Cycle, Entrapment of Device, Difficult to Remove, Failure to Fire, Deformation Due to Compressive Stress
2018-06-21 Injury None Improper or Incorrect Procedure or Method, Failure to Fire
2018-06-18 Injury None Malposition of Device
2018-06-18 Injury None Malposition of Device
2018-06-06 Injury None Positioning Failure, Difficult to Remove, Retraction Problem, Improper or Incorrect Procedure or Method
2018-06-06 Injury None Positioning Failure
2018-04-19 Injury None Positioning Failure, Difficult to Remove, Retraction Problem
2018-04-16 Injury None Positioning Failure, Device Damaged by Another Device
2018-04-05 Injury None Device Operates Differently Than Expected
2018-02-28 Malfunction None Device Operates Differently Than Expected
2018-02-28 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2018-02-07 Injury None Positioning Failure
2018-02-05 Injury None Positioning Failure
2018-01-22 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2018-01-20 Malfunction None Difficult to Insert
2018-01-19 Injury None Positioning Failure
2018-01-15 Malfunction None Difficult to Insert
2018-01-04 Injury None Partial Blockage, Positioning Failure, Difficult to Insert
2017-12-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-08 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2017-11-08 Injury None Insufficient Information
2017-10-27 Injury None Partial Blockage
2017-10-25 Injury None Partial Blockage
2017-10-25 Injury None Partial Blockage
2017-10-01 Injury None Patient Device Interaction Problem
2017-09-20 Injury None Partial Blockage, Physical Property Issue
2017-09-15 Injury None Insufficient Information
2017-09-07 Injury None Device Operates Differently Than Expected
2017-09-07 Injury None Difficult or Delayed Positioning, Device Operates Differently Than Expected
2017-09-07 Injury None Difficult or Delayed Positioning, Device Operates Differently Than Expected
2017-09-01 Injury Obstruction/Occlusion None
2017-08-31 Injury None Positioning Failure, Difficult to Remove
2017-08-11 Injury None Device Operates Differently Than Expected
2017-07-25 Injury None Positioning Failure
2017-07-20 Injury None Device Operates Differently Than Expected
2017-07-18 Malfunction None Difficult to Insert
2017-07-11 Malfunction None Difficult to Insert
2017-07-05 Injury None Difficult to Remove, Device Operates Differently Than Expected
2017-07-04 Malfunction None Difficult to Insert
2017-06-20 Injury None Positioning Failure
2017-06-09 Malfunction None Partial Blockage, Difficult to Insert
2017-06-09 Malfunction None Difficult to Insert
2017-05-29 Injury None Partial Blockage
2017-05-24 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2017-05-24 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2017-05-23 Injury None Detachment Of Device Component
2017-05-19 Injury None Improper or Incorrect Procedure or Method
2017-05-19 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2017-05-15 Injury None Detachment Of Device Component
2017-05-15 Injury None Detachment Of Device Component
2017-04-20 Injury None Difficult to Insert
2017-04-20 Injury None Difficult to Insert
2017-04-19 Malfunction None Difficult to Insert
2017-03-29 Injury None Device Operates Differently Than Expected
2017-03-29 Injury None Device Operates Differently Than Expected
2017-03-09 Injury None Positioning Failure
2017-03-01 Injury None Insufficient Information
2017-03-01 Injury None Partial Blockage
2017-02-08 Malfunction None Difficult to Remove
2017-02-08 Malfunction None Difficult to Remove
2017-01-18 Injury None Device Operates Differently Than Expected
2017-01-18 Injury None Device Operates Differently Than Expected
2017-01-18 Injury None Device Operates Differently Than Expected
2017-01-16 Injury None Positioning Failure
2017-01-07 Injury None Positioning Failure
2017-01-07 Injury None Positioning Failure
2017-01-07 Injury None Positioning Failure
2017-01-07 Injury None Positioning Failure
2017-01-05 Injury None Device Operates Differently Than Expected
2017-01-05 Injury None Difficult to Insert, Device Operates Differently Than Expected
2017-01-05 Injury None Difficult to Insert, Device Operates Differently Than Expected
2017-01-01 Injury Obstruction/Occlusion Insufficient Information
2017-01-01 Injury None Positioning Failure
2017-01-01 Death Unspecified Vascular Problem Adverse Event Without Identified Device or Use Problem
2016-12-19 Injury None Bent, Positioning Failure, Difficult to Remove
2016-12-18 Injury None Difficult to Insert
2016-12-18 Injury None Difficult to Insert
2016-12-18 Injury None Difficult to Insert
2016-12-14 Injury None Difficult to Insert
2016-12-13 Injury None Difficult to Insert
2016-12-07 Injury None Positioning Failure
2016-12-06 Death None Device Operates Differently Than Expected
2016-11-29 Injury None Positioning Failure
2016-11-28 Malfunction None Difficult to Remove
2016-11-25 Malfunction None Difficult to Remove
2016-11-25 Malfunction None Difficult to Remove
2016-11-21 Injury None Difficult to Insert
2016-11-17 Injury None Difficult to Remove, Improper or Incorrect Procedure or Method
2016-11-17 Injury None Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Positioning Failure
2016-11-03 Injury None Device Operates Differently Than Expected
2016-11-03 Injury None Device Operates Differently Than Expected
2016-11-01 Injury None Device Operates Differently Than Expected
2016-10-28 Injury None Device Operates Differently Than Expected
2016-10-26 Malfunction None Device Operates Differently Than Expected
2016-10-03 Injury None Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected
2016-10-01 Death None Device Operates Differently Than Expected
2016-10-01 Injury None Device Operates Differently Than Expected
2016-09-26 Injury None Partial Blockage, Improper or Incorrect Procedure or Method
2016-09-26 Injury None Partial Blockage, Improper or Incorrect Procedure or Method
2016-09-19 Injury None Detachment Of Device Component, Positioning Failure
2016-09-09 Injury None Positioning Failure
2016-09-06 Injury None Device Operates Differently Than Expected
2016-08-29 Injury None Device Operates Differently Than Expected
2016-08-18 Injury None Difficult or Delayed Positioning
2016-07-27 Injury None Positioning Failure
2016-07-25 Injury None Partial Blockage, Improper or Incorrect Procedure or Method
2016-07-25 Injury None Partial Blockage, Improper or Incorrect Procedure or Method
2016-07-25 Injury None Improper or Incorrect Procedure or Method
2016-07-19 Injury None Device Operates Differently Than Expected
2016-07-15 Injury None Detachment Of Device Component
2016-06-28 Injury None Positioning Failure
2016-06-28 Injury None Positioning Failure
2016-06-28 Injury None Positioning Failure
2016-06-27 Injury None Device Operates Differently Than Expected
2016-06-27 Injury None Device Operates Differently Than Expected
2016-06-17 Injury None Device Operates Differently Than Expected
2016-01-01 Injury No Clinical Signs, Symptoms or Conditions None
2016-01-01 Injury Unspecified Tissue Injury None
2015-05-06 Injury None Positioning Failure
2015-05-06 Injury None Positioning Failure
2015-04-13 Injury None Positioning Failure
2015-04-13 Injury None Positioning Failure
2014-07-23 Injury None Device Operates Differently Than Expected
2014-07-21 Malfunction None Device Operates Differently Than Expected
2014-07-21 Injury None Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected
2014-07-21 Injury None Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected
2014-07-17 Malfunction None Device Packaging Compromised
2014-07-15 Injury None Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected
2014-07-06 Injury None Device Operates Differently Than Expected
2014-07-06 Injury None Device Operates Differently Than Expected
2014-06-27 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2014-06-26 Injury None Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected
2014-06-24 Injury None Detachment Of Device Component
2014-06-24 Injury None Difficult to Insert, Improper or Incorrect Procedure or Method
2014-06-24 Injury None Difficult to Insert, Improper or Incorrect Procedure or Method
2014-06-24 Injury None Difficult to Insert, Improper or Incorrect Procedure or Method
2014-06-03 Injury None Detachment Of Device Component
2014-06-03 Injury None Detachment Of Device Component
2014-05-28 Malfunction None Device Operates Differently Than Expected
2014-05-16 Injury None Partial Blockage
2014-05-16 Injury None Device Operates Differently Than Expected
2014-05-16 Injury None Device Operates Differently Than Expected
2014-05-07 Injury None Device Operates Differently Than Expected
2014-05-05 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2014-04-30 Malfunction None Device Operates Differently Than Expected
2014-04-29 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2014-04-25 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2014-04-11 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2014-04-08 Injury None Device Operates Differently Than Expected
2014-04-08 Injury None Device Operates Differently Than Expected
2014-04-02 Injury None Device Operates Differently Than Expected
2014-03-20 Injury None Device Operates Differently Than Expected
2014-03-20 Injury None Device Operates Differently Than Expected
2014-03-14 Injury None Improper or Incorrect Procedure or Method
2014-03-14 Injury None Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected
2014-03-13 Injury None Detachment Of Device Component
2014-03-12 Injury None Difficult to Insert
2014-03-12 Injury None Difficult or Delayed Positioning, Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected
2014-03-06 Malfunction None Difficult to Insert, Device Operates Differently Than Expected
2014-02-26 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2014-02-25 Injury None Positioning Failure
2014-02-18 Injury None Positioning Failure
2014-02-06 Injury None Premature Activation
2014-02-05 Injury None Positioning Failure, Improper or Incorrect Procedure or Method
2014-01-27 Injury None Positioning Failure
2014-01-27 Injury None Positioning Failure, Difficult to Remove
2014-01-14 Malfunction None Difficult to Insert
2014-01-07 Malfunction None Partial Blockage
2013-12-17 Malfunction None Difficult to Insert
2013-12-17 Malfunction None Difficult to Insert
2013-12-10 Injury None Positioning Failure
2013-12-09 Malfunction None Positioning Failure
2013-12-09 Injury None Positioning Failure
2013-12-09 Injury None None
2013-12-09 Injury None Improper or Incorrect Procedure or Method
2013-12-09 Malfunction None Material Protrusion/Extrusion
2013-11-18 Injury None None
2013-11-13 Injury None None
2013-11-12 Injury None None
2013-11-05 Injury None None
2013-10-28 Injury None None
2013-10-24 Injury None None
2013-10-22 Injury None None
2013-10-21 Injury None None
2013-09-26 Injury None None
2013-09-20 Injury None None
2013-09-19 Injury None None
2013-09-19 Injury None None
2013-09-19 Injury None None
2013-09-12 Injury None None
2013-09-12 Injury None None
2013-09-10 Injury None None
2013-08-27 Injury None None
2013-08-22 Injury None None
2013-08-06 Injury None None
2013-08-01 Injury None None
2013-07-23 Injury None None
2013-07-23 Injury None None
2013-07-17 Malfunction None None
2013-07-15 Injury None None
2013-07-15 Injury None None
2013-07-12 Injury None None
2013-07-10 Injury None None
2013-07-03 Injury None None
2013-07-03 Injury None None
2013-07-03 Injury None None
2013-06-26 Injury None None
2013-06-19 Injury None None
2013-05-22 Injury None None
2013-05-15 Injury None None
2013-04-25 Injury None None
2013-04-15 Malfunction None None
2013-04-10 Injury None None
2013-04-08 Injury None None
2013-04-04 Injury None None
2013-04-04 Injury None None
2013-04-03 Injury None None
2013-04-03 Injury None None
2013-04-03 Injury None None
2013-03-22 Injury None None
2013-03-21 Injury None None
2013-03-19 Injury None None
2013-03-08 Injury None None
2013-03-05 Injury None None
2013-03-01 Injury None None
2013-02-15 Injury None None
2013-02-15 Injury None None
2013-02-15 Injury None None
2013-02-08 Injury None None
2013-02-07 Injury None None
2013-02-07 Injury None None
2013-02-04 Injury None None
2013-01-24 Injury None None
2013-01-23 Injury None None
2013-01-22 Injury None None
2013-01-09 Injury None None
2013-01-05 Injury None None
2013-01-01 Injury None None
2013-01-01 Injury None None
2012-12-19 Injury None None
2012-12-19 Injury None None
2012-12-11 Malfunction None None
2012-12-11 Injury None None
2012-11-30 Injury None None
2012-11-30 Injury None None
2012-11-23 Injury None None
2012-11-22 Injury None None
2012-11-21 Injury None None
2012-11-20 Injury None None
2012-11-20 Injury None None
2012-11-19 Injury None None
2012-11-13 Injury None None
2012-11-08 Injury None None
2012-11-08 Injury None None
2012-11-08 Injury None None
2012-11-05 Injury None None
2012-10-29 Injury None None
2012-10-29 Injury None None
2012-10-29 Injury None None
2012-10-25 Injury None None
2012-10-16 Injury None None
2012-10-12 Injury None None
2012-10-10 Injury None None
2012-10-10 Injury None None
2012-10-10 Injury None None
2012-10-08 Injury None None
2012-10-01 Injury None None
2012-09-27 Injury None None
2012-09-23 Injury None None
2012-09-23 Injury None None
2012-09-23 Injury None None
2012-09-23 Injury None None
2012-09-23 Injury None None
2012-09-19 Injury None None
2012-09-19 Injury None None
2012-09-19 Injury None None
2012-09-14 Injury None None
2012-09-10 Injury None None
2012-09-10 Injury None None
2012-09-10 Injury None None
2012-09-10 Injury None None
2012-09-06 Injury None None
2012-09-05 Injury None None
2012-09-05 Injury None None
2012-08-30 Injury None None
2012-08-28 Injury None None
2012-08-20 Injury None None
2012-08-14 Injury None None
2012-08-14 Injury None None
2012-08-14 Injury None None
2012-08-14 Injury None None
2012-08-10 Injury None None
2012-08-10 Injury None None
2012-08-08 Injury None None
2012-07-31 Injury None None
2012-07-13 Injury None None
2012-07-13 Injury None None
2012-07-13 Injury None None
2012-07-12 Injury None None
2012-07-12 Injury None None
2012-07-11 Injury None None
2012-07-11 Injury None None
2012-07-11 Injury None None
2012-07-10 Injury None None
2012-07-10 Injury None None
2012-06-27 Injury None None
2012-06-26 Injury None None
2012-06-15 Injury None None
2012-06-13 Injury None None
2012-06-12 Injury None None
2012-06-12 Injury None None
2012-06-07 Injury None None
2012-06-01 Injury None None
2012-05-29 Injury None None
2012-05-25 Injury None None
2012-05-25 Injury None None
2012-05-22 Injury None None
2012-05-21 Injury None None
2012-05-17 Injury None None
2012-05-11 Injury None None
2012-05-10 Injury None None
2012-05-03 Injury None None
2012-05-03 Injury None None
2012-05-02 Death None None
2012-05-02 Injury None None
2012-05-01 Injury None Device Operates Differently Than Expected
2012-05-01 Injury None None
2012-04-30 Injury None None
2012-04-18 Injury None None
2012-04-18 Injury None None
2012-04-17 Injury None None
2012-04-17 Injury None None
2012-04-17 Injury None None
2012-04-16 Injury None None
2012-04-10 Death None None
2012-04-03 Injury None None
2012-03-21 Injury None None
2012-03-19 Injury None None
2012-03-15 Injury None None
2012-03-14 Injury None None
2012-03-09 Injury None None
2012-03-08 Injury None None
2012-03-07 Injury None None
2012-03-06 Injury None None
2012-03-02 Injury None None
2012-03-01 Injury None None
2012-03-01 Injury None None
2012-03-01 Injury None None
2012-03-01 Injury None None
2012-03-01 Injury None None
2012-02-27 Injury None None
2012-02-27 Injury None None
2012-02-27 Injury None None
2012-02-23 Injury None None
2012-02-22 Injury None None
2012-02-21 Injury None None
2012-02-21 Injury None None
2012-02-21 Injury None None
2012-02-15 Injury None None
2012-02-15 Injury None None
2012-02-15 Injury None None
2012-02-13 Injury None None
2012-02-09 Injury None None
2012-02-08 Injury None None
2012-02-08 Injury None None
2012-02-01 Injury None None
2012-02-01 Injury None None
2012-02-01 Injury None None
2012-01-29 Injury None None
2012-01-26 Injury None None
2012-01-25 Injury None None
2012-01-20 Injury None None
2012-01-20 Injury None None
2012-01-18 Injury None None
2012-01-18 Injury None None
2012-01-18 Injury None None
2012-01-17 Injury None None
2012-01-12 Injury None None
2012-01-12 Injury None None
2012-01-10 Injury None None
2012-01-09 Injury None None
2012-01-05 Injury None None
2011-12-29 Injury None None
2011-12-28 Injury None None
2011-12-28 Injury None None
2011-12-22 Injury None None
2011-12-20 Injury None None
2011-12-14 Injury None None
2011-12-12 Injury None None
2011-12-12 Injury None None
2011-12-08 Injury None None
2011-12-08 Injury None None
2011-12-05 Injury None None
2011-12-01 Injury None None
2011-12-01 Injury None None
2011-11-30 Injury None None
2011-11-29 Injury None None
2011-11-21 Injury None None
2011-11-21 Injury None None
2011-11-21 Injury None None
2011-11-21 Injury None None
2011-11-21 Injury None None
2011-11-14 Injury None None
2011-11-14 Injury None None
2011-11-10 Injury None None
2011-11-10 Injury None None
2011-11-03 Injury None None
2011-11-03 Injury None None
2011-11-03 Injury None None
2011-11-02 Injury None None
2011-11-01 Injury None None
2011-11-01 Injury None None
2011-11-01 Injury None None
2011-10-26 Injury None None
2011-10-24 Injury None None
2011-10-24 Injury None None
2011-10-20 Injury None None
2011-10-20 Injury None None
2011-10-20 Injury None None
2011-10-20 Injury None None
2011-10-19 Injury None None
2011-10-17 Injury None None
2011-10-17 Injury None None
2011-10-17 Injury None None
2011-10-11 Injury None None
2011-10-01 Injury None None
2011-09-26 Injury None None
2011-09-26 Injury None None
2011-09-26 Injury None None
2011-09-23 Injury None None
2011-09-23 Injury None None
2011-09-13 Injury None None
2011-09-08 Injury None None
2011-09-07 Injury None None
2011-09-06 Injury None None
2011-09-02 Injury None None
2011-09-01 Injury None None
2011-09-01 Injury None None
2011-08-30 Injury None None
2011-08-29 Injury None None
2011-08-29 Injury None None
2011-08-15 Injury None None
2011-08-15 Injury None None
2011-08-11 Injury None None
2011-08-10 Injury None None
2011-08-03 Injury None None
2011-08-03 Injury None None
2011-08-01 Injury None None
2011-07-30 Injury None None
2011-07-25 Injury None None
2011-07-25 Injury None None
2011-07-25 Injury None None
2011-07-25 Injury None None
2011-07-25 Injury None None
2011-07-25 Injury None None
2011-07-21 Injury None None
2011-07-20 Injury None None
2011-07-20 Injury None None
2011-07-19 Injury None None
2011-07-14 Injury None None
2011-07-11 Injury None None
2011-07-07 Injury None None
2011-07-07 Injury None None
2011-07-05 Injury None None
2011-07-05 Injury None None
2011-07-01 Injury None None
2011-07-01 Injury None None
2011-07-01 Malfunction None None
2011-06-29 Injury None None
2011-06-29 Injury None None
2011-06-29 Injury None None
2011-06-21 Injury None None
2011-06-21 Injury None None
2011-06-20 Injury None None
2011-06-16 Injury None None
2011-06-14 Injury None None
2011-06-14 Injury None None
2011-06-09 Injury None None
2011-06-08 Injury None None
2011-06-08 Injury None None
2011-06-08 Injury None None
2011-06-08 Injury None None
2011-06-07 Injury None None
2011-06-07 Injury None None
2011-06-06 Injury None None
2011-06-03 Injury None None
2011-06-02 Injury None None
2011-06-01 Death None None
2011-06-01 Injury None None
2011-06-01 Injury None None
2011-06-01 Injury None None
2011-05-31 Injury None None
2011-05-31 Injury None None
2011-05-31 Injury None None
2011-05-31 Injury None None
2011-05-30 Injury None None
2011-05-26 Injury None None
2011-05-26 Injury None None
2011-05-25 Injury None None
2011-05-25 Injury None None
2011-05-24 Injury None None
2011-05-24 Injury None None
2011-05-24 Injury None None
2011-05-23 Injury None None
2011-05-23 Injury None None
2011-05-20 Injury None None
2011-05-20 Injury None None
2011-05-18 Injury None None
2011-05-16 Injury None None
2011-05-13 Injury None None
2011-05-13 Injury None None
2011-05-13 Injury None None
2011-05-12 Injury None None
2011-05-12 Injury None None
2011-05-12 Injury None None
2011-05-11 Injury None None
2011-05-10 Malfunction None None
2011-05-10 Malfunction None None
2011-05-09 Injury None None
2011-05-09 Injury None None
2011-05-05 Injury None None
2011-05-02 Injury None None
2011-05-02 Injury None None
2011-04-28 Injury None None
2011-04-27 Injury None None
2011-04-26 Injury None None
2011-04-26 Injury None None
2011-04-21 Injury None None
2011-04-19 Injury None None
2011-04-19 Injury None None
2011-04-19 Injury None None
2011-04-19 Injury None None
2011-04-19 Injury None None
2011-04-15 Injury None None
2011-04-13 Injury None None
2011-04-13 Injury None None
2011-04-12 Injury None None
2011-04-12 Injury None None
2011-04-12 Injury None None
2011-04-12 Injury None None
2011-04-11 Injury None None
2011-03-29 Death None None
2011-03-28 Injury None None
2011-03-28 Injury None None
2011-03-24 Injury None None
2011-03-24 Injury None None
2011-03-24 Injury None None
2011-03-24 Injury None None
2011-03-24 Injury None None
2011-03-24 Injury None None
2011-03-23 Injury None None
2011-03-22 Death None None
2011-03-22 Injury None None
2011-03-22 Injury None None
2011-03-21 Injury None None
2011-03-17 Injury None None
2011-03-16 Injury None None
2011-03-14 Injury None None
2011-03-10 Injury None None
2011-03-09 Injury None None
2011-03-04 Injury None None
2011-03-03 Injury None None
2011-03-02 Injury None None
2011-03-01 Injury None None
2011-03-01 Injury None None
2011-02-23 Injury None None
2011-02-23 Injury None None
2011-02-21 Malfunction None None
2011-02-21 Injury None None
2011-02-21 Injury None None
2011-02-21 Injury None None
2011-02-21 Injury None None
2011-02-16 Malfunction None None
2011-02-15 Injury None None
2011-02-10 Injury None None
2011-02-09 Injury None None
2011-02-09 Injury None None
2011-02-09 Injury None None
2011-02-09 Injury None None
2011-02-09 Injury None None
2011-02-02 Injury None None
2011-01-28 Injury None None
2011-01-26 Injury None None
2011-01-26 Injury None None
2011-01-26 Injury None None
2011-01-24 Injury None None
2011-01-24 Injury None None
2011-01-24 Injury None None
2011-01-24 Injury None None
2011-01-21 Injury None None
2011-01-11 Injury None None
2011-01-06 Injury None None
2011-01-05 Injury None None
2011-01-05 Injury None None
2011-01-05 Injury None None
2011-01-01 Injury None None
2011-01-01 Death None None
2010-12-30 Injury None None
2010-12-30 Injury None None
2010-12-30 Injury None None
2010-12-17 Injury None None
2010-12-16 Injury None None
2010-12-14 Injury None None
2010-12-07 Injury None None
2010-12-07 Injury None None
2010-12-07 Injury None None
2010-12-02 Injury None None
2010-12-02 Malfunction None None
2010-12-02 Injury None None
2010-12-02 Malfunction None None
2010-12-01 Injury None None
2010-11-22 Injury None None
2010-11-22 Injury None None
2010-11-21 Injury None None
2010-11-18 Injury None None
2010-11-18 Injury None None
2010-11-18 Injury None None
2010-11-17 Injury None None
2010-11-15 Injury None None
2010-11-14 Injury None None
2010-11-14 Injury None None
2010-11-14 Injury None None
2010-11-11 Injury None None
2010-11-11 Injury None None
2010-11-10 Injury None None
2010-11-10 Injury None None
2010-11-09 Injury None None
2010-11-09 Injury None None
2010-11-04 Malfunction None None
2010-11-01 Injury None None
2010-11-01 Injury None None
2010-11-01 Injury None None
2010-10-29 Injury None None
2010-10-26 Injury None None
2010-10-01 Injury None None
2010-09-29 Injury None None
2010-09-28 Injury None None
2010-09-23 Injury None None
2010-07-29 Injury None None
2010-07-28 Injury None None
2010-07-28 Injury None None
2010-04-01 Injury None None
2010-02-15 Injury None Device Operates Differently Than Expected
2010-01-01 Injury None None
2010-01-01 Injury None None
2010-01-01 Injury None None
2010-01-01 Death None None
2010-01-01 Injury None None
2010-01-01 Injury None None
2009-12-14 Injury None None
2009-06-01 Injury None Insufficient Information
2009-03-01 Injury None Device Operates Differently Than Expected
2008-08-01 Death None None
2008-08-01 Injury None None
2008-01-01 Injury None Device Operates Differently Than Expected
2008-01-01 Death None None
2008-01-01 Death None Adverse Event Without Identified Device or Use Problem
2007-01-01 Injury None Device Operates Differently Than Expected
2005-01-01 Injury No Clinical Signs, Symptoms or Conditions None
2005-01-01 Injury Hemorrhage/Blood Loss/Bleeding None
2005-01-01 Injury No Clinical Signs, Symptoms or Conditions None
2005-01-01 Injury Hemorrhage/Blood Loss/Bleeding, Unspecified Infection, Pseudoaneurysm, Thrombosis/Thrombus None
2004-01-01 Injury None None
2004-01-01 Injury None None
2004-01-01 Injury Fatigue, Hematoma, Unspecified Infection, Ischemia, Pain, Stenosis, Numbness, Obstruction/Occlusion, Pseudoaneurysm, Vascular Dissection, Thrombosis/Thrombus None
2004-01-01 Injury None None
2004-01-01 Injury None None
2004-01-01 Injury None None
2004-01-01 Injury None None
2004-01-01 Injury None None
2004-01-01 Injury None None
1999-01-01 Injury None None