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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 2017
0 0 1 1 14 10 10 15 15 19 2

Device Problems
No Known Device Problem 117
No code available 46
No Information 37
Material integrity issue 22
Not Applicable 16
Air leak 15
Device operates differently than expected 10
Device displays error message 8
Device contamination with blood or blood product 7
Suction issue 4
Positioning Issue 4
Temperature issue 3
Difficult to advance 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
Human-Device Interface Issue 1
Improper flow or infusion 1
Infusion or flow issue 1
Material deformation 1
Packaging issue 1
Protective measure issue 1
Total Device Problems 318

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 1 1 0 0 2 0 0
Class III 0 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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