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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
0 0 0 0 0 0 0 0 4 6

Device Problems
No Known Device Problem 343
Difficult to remove 61
Leak 34
Kinked 30
Bent 11
Torn material 10
Detachment of device or device component 6
Air leak 6
Difficult to open or close 4
Material deformation 4
Foreign material present in device 1
Unintended movement 1
Device or device component damaged by another device 1
Split 1
Deployment issue 1
Premature deployment 1
Material puncture 1
Break 1
Difficult to deploy 1
Fluid leak 1
Difficult to flush 1
Hole in material 1
Total Device Problems 521

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