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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, appendage closure, left atrial
Product CodeNGV
Device Class Not Classified

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 4 8 1

Device Problems
No Known Device Problem 653
Difficult to remove 110
Leak 57
Kinked 47
Torn material 24
Air leak 17
Bent 15
Detachment of device or device component 6
Material deformation 6
Difficult to open or close 4
Premature deployment 4
Deployment issue 3
Hole in material 2
Break 2
Material Protrusion 2
Foreign material present in device 2
Unintended movement 1
Difficult to open or remove packaging material 1
Detachment of device component 1
Difficult to deploy 1
Fluid leak 1
Difficult to flush 1
Difficult to insert 1
Material puncture 1
Device or device component damaged by another device 1
Device damaged prior to use 1
Failure to advance 1
Split 1
Physical resistance 1
Disinfection or Sterilization Issue at User Location 1
Total Device Problems 968

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Nov-11-2015

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