466FXXXX

FILTER, INTRAVASCULAR, CARDIOVASCULAR

This device is manufactured by CORDIS CASHEL, CORDIS CORPORATION.

The following problems were reported about this device:

Year Description Events/year Type
2022 Migration 2 Device
2022 Adverse Event Without Identified Device or Use Problem 2 Device
2021 Unintended Movement 2 Device
2021 Occlusion Within Device 1 Device
2021 Obstruction of Flow 1 Device
2021 Fracture 3 Device
2021 Failure to Align 4 Device
2021 Difficult to Remove 1 Device
2020 Unintended Movement 1 Device
2020 Occlusion Within Device 1 Device
2020 Fracture 5 Device
2020 Failure to Align 7 Device
2019 Unintended Movement 4 Device
2019 Therapeutic or Diagnostic Output Failure 1 Device
2019 Obstruction of Flow 1 Device
2019 Migration 10 Device
2019 Material Twisted/Bent 1 Device
2019 Material Perforation 2 Device
2019 Malposition of Device 1 Device
2019 Fracture 12 Device
2019 Failure to Align 70 Device
2019 Difficult to Remove 29 Device
2019 Defective Device 3 Device
2019 Defective Component 1 Device
2019 Appropriate Term/Code Not Available 2 Device
2019 Adverse Event Without Identified Device or Use Problem 30 Device
2019 Activation Failure 1 Device
2018 Unintended Movement 13 Device
2018 Therapeutic or Diagnostic Output Failure 1 Device
2018 Retraction Problem 1 Device
2018 Protective Measures Problem 1 Device
2018 Obstruction of Flow 2 Device
2018 Migration or Expulsion of Device 2 Device
2018 Migration 2 Device
2018 Material Protrusion/Extrusion 1 Device
2018 Fracture 32 Device
2018 Failure to Align 72 Device
2018 Difficult to Remove 27 Device
2018 Device Operates Differently Than Expected 1 Device
2018 Detachment of Device or Device Component 1 Device
2018 Defective Component 1 Device
2018 Appropriate Term/Code Not Available 1 Device
2018 Adverse Event Without Identified Device or Use Problem 40 Device
2017 Unintended Movement 36 Device
2017 Retraction Problem 1 Device
2017 Patient-Device Incompatibility 1 Device
2017 Occlusion Within Device 6 Device
2017 Migration or Expulsion of Device 1 Device
2017 Migration 2 Device
2017 Mechanical Problem 1 Device
2017 Fracture 32 Device
2017 Filtration Problem 1 Device
2017 Failure to Align 119 Device
2017 Entrapment of Device 1 Device
2017 Difficult to Remove 66 Device
2017 Device Inoperable 1 Device
2017 Defective Device 2 Device
2017 Defective Component 2 Device
2017 Complete Blockage 2 Device
2017 Bent 2 Device
2017 Appropriate Term/Code Not Available 1 Device
2017 Adverse Event Without Identified Device or Use Problem 71 Device
2016 Unintended Movement 9 Device
2016 Unexpected Therapeutic Results 1 Device
2016 Retraction Problem 1 Device
2016 Protective Measures Problem 1 Device
2016 Output Problem 1 Device
2016 Occlusion Within Device 9 Device
2016 Migration or Expulsion of Device 1 Device
2016 Migration 1 Device
2016 Fracture 14 Device
2016 Failure to Align 31 Device
2016 Difficult to Remove 44 Device
2016 Appropriate Term/Code Not Available 1 Device
2016 Adverse Event Without Identified Device or Use Problem 42 Device
2015 Unintended Movement 5 Device
2015 Unexpected Therapeutic Results 1 Device
2015 Occlusion Within Device 5 Device
2015 Fracture 8 Device
2015 Failure to Align 15 Device
2015 Difficult to Remove 15 Device
2015 Defective Component 1 Device
2015 Adverse Event Without Identified Device or Use Problem 9 Device
2014 Unintended Movement 6 Device
2014 Occlusion Within Device 4 Device
2014 Fracture 4 Device
2014 Failure to Align 11 Device
2014 Difficult to Remove 12 Device
2014 Adverse Event Without Identified Device or Use Problem 4 Device
2013 Unintended Movement 6 Device
2013 Retraction Problem 1 Device
2013 Migration or Expulsion of Device 1 Device
2013 Fracture 3 Device
2013 Failure to Align 7 Device
2013 Difficult to Remove 5 Device
2013 Defective Component 1 Device
2013 Adverse Event Without Identified Device or Use Problem 3 Device
2012 Unintended Movement 1 Device
2012 Occlusion Within Device 1 Device
2012 Fracture 1 Device
2012 Failure to Align 7 Device
2012 Difficult to Remove 10 Device
2012 Adverse Event Without Identified Device or Use Problem 5 Device
2011 Unintended Movement 5 Device
2011 Therapy Delivered to Incorrect Body Area 1 Device
2011 Occlusion Within Device 2 Device
2011 Fracture 3 Device
2011 Failure to Align 8 Device
2011 Difficult to Remove 14 Device
2011 Adverse Event Without Identified Device or Use Problem 11 Device
2011 Activation Failure 1 Device
2010 Unintended Movement 2 Device
2010 Fracture 1 Device
2010 Failure to Align 3 Device
2010 Difficult to Remove 7 Device
2010 Device Markings/Labelling Problem 1 Device
2010 Adverse Event Without Identified Device or Use Problem 3 Device
2009 Unintended Movement 2 Device
2009 Therapy Delivered to Incorrect Body Area 1 Device
2009 Separation Failure 1 Device
2009 Occlusion Within Device 1 Device
2009 Failure to Align 3 Device
2009 Difficult to Remove 10 Device
2009 Defective Device 1 Device
2009 Appropriate Term/Code Not Available 1 Device
2009 Adverse Event Without Identified Device or Use Problem 7 Device
2008 Unintended Movement 1 Device
2008 Obstruction of Flow 1 Device
2008 Migration 1 Device
2008 Fracture 1 Device
2008 Failure to Align 3 Device
2008 Difficult to Remove 3 Device
2008 Adverse Event Without Identified Device or Use Problem 1 Device
2007 Unintended Movement 1 Device
2007 Occlusion Within Device 1 Device
2007 Fracture 1 Device
2007 Failure to Align 4 Device
2007 Difficult to Remove 6 Device
2007 Adverse Event Without Identified Device or Use Problem 1 Device
2006 Unintended Movement 2 Device
2006 Fracture 3 Device
2006 Failure to Align 4 Device
2006 Difficult to Remove 7 Device
2005 Failure to Align 1 Device
2005 Difficult to Remove 1 Device
2005 Adverse Event Without Identified Device or Use Problem 1 Device
2004 Failure to Align 1 Device
2004 Difficult to Remove 2 Device
2004 Defective Device 1 Device
2004 Adverse Event Without Identified Device or Use Problem 1 Device
2003 Failure to Align 1 Device
2003 Difficult to Remove 2 Device
2003 Adverse Event Without Identified Device or Use Problem 1 Device