• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 7

Device Problems
No Known Device Problem 446
Difficult to remove 72
Leak 43
Kinked 34
Torn material 14
Bent 13
Air leak 9
Detachment of device or device component 6
Material deformation 5
Difficult to open or close 4
Foreign material present in device 2
Hole in material 2
Break 2
Detachment of device component 1
Difficult to deploy 1
Fluid leak 1
Difficult to flush 1
Premature deployment 1
Material puncture 1
Device or device component damaged by another device 1
Device damaged prior to use 1
Split 1
Deployment issue 1
Unintended movement 1
Total Device Problems 663

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

-
-