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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Definition For the treatment of atrial fibrillation.
Product CodeOAE
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 1 1 14 10 10 15 15 16

Device Problems
No Known Device Problem 66
No Information 37
Material integrity issue 21
Not Applicable 15
Device operates differently than expected 10
No code available 9
Device displays error message 8
Device contamination with blood or blood product 5
Air leak 4
Positioning Issue 4
Suction issue 4
Difficult to advance 3
Temperature issue 3
Fluid leak 3
Alarm, error of warning 2
Aspiration issue 2
Device disinfection or sterilization issue 1
Application program version or upgrade problem 1
Tear, rip or hole in device packaging 1
Malfunction 1
Obstruction within device 1
Failure to advance 1
Contamination during use 1
Deflation issue 1
Disconnection 1
Kinked 1
Decrease in pressure 1
Material rupture 1
Sticking 1
Protective measure issue 1
Human-Device Interface Issue 1
Improper flow or infusion 1
Infusion or flow issue 1
Material deformation 1
Packaging issue 1
Total Device Problems 215

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 1 1 0 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster, Inc. II May-28-2015
2 Biosense Webster, Inc. II Feb-07-2012
3 Medtronic Inc. Cardiac Rhythm Disease Management II Nov-02-2011
4 St Jude Medical II Mar-17-2015

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