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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 11

Device Problems
No Known Device Problem 301
No code available 72
Air leak 44
No Information 37
Material integrity issue 26
Not Applicable 18
Fluid leak 12
Device operates differently than expected 10
Device displays error message 8
Device contamination with blood or blood product 8
Suction issue 4
Positioning Issue 4
Temperature issue 3
Communication or transmission issue 3
Difficult to advance 3
Leak 3
Alarm, error of warning 2
Aspiration issue 2
Device disinfection or sterilization issue 1
Foreign material present in device 1
Human-Device Interface Issue 1
Improper flow or infusion 1
Infusion or flow issue 1
Material deformation 1
Tear, rip or hole in device packaging 1
Malfunction 1
Obstruction within device 1
Failure to advance 1
Ambient noise issue 1
Application program version or upgrade problem 1
High impedance 1
Kinked 1
Artifact 1
Break 1
Contamination during use 1
Deflation issue 1
Disconnection 1
No display or display failure 1
Difficult to position 1
Decrease in pressure 1
Difficult to remove 1
Material rigid or stiff 1
Material rupture 1
Failure to read input signal 1
Sticking 1
Improper or incorrect procedure or method 1
Protective measure issue 1
Optical issue 1
Packaging issue 1
Total Device Problems 591

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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