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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, steerable
Regulation Description Steerable catheter.
Product CodeDRA
Regulation Number 870.1280
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
CARDIOFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYOCATH TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
EKOS CORP.
  SUBSTANTIALLY EQUIVALENT 1
EVALVE INC
  SUBSTANTIALLY EQUIVALENT 4
HANSEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
HANSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Air leak 217
No Known Device Problem 148
No code available 142
Not Applicable 94
Fluid leak 81
Leak 43
Kinked 35
Material integrity issue 22
Detachment of device component 21
No Information 12
Mislabeled 10
Difficult to remove 10
Unstable 10
Break 9
Difficult to insert 7
Device operates differently than expected 7
Torn material 5
Delivered as unsterile product 5
Aspiration issue 4
Failure to advance 3
Physical resistance 3
Loss of or failure to bond 3
Device displays error message 2
Detachment of device or device component 2
Slippage of device or device component 2
Difficult to position 2
Device Difficult to Setup or Prepare 1
Loose or intermittent connection 1
Mechanical issue 1
Tip breakage 1
Material separation 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Suction issue 1
Obstruction within device 1
Balloon rupture 1
Bent 1
Contamination during use 1
Crack 1
Deflation issue 1
Occlusion within device 1
Peeled 1
High impedance 1
Hole in material 1
Unintended movement 1
Device or device component damaged by another device 1
Difficult to advance 1
Dislodged or dislocated 1
Material twisted 1
Positioning Issue 1
Total Device Problems 923

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

Recalls
Manufacturer Recall Class Date Posted
1 Greatbatch Medical II Sep-26-2012
2 Hansen Medical Inc II Sep-11-2008
3 Medtronic Inc. Cardiac Rhythm Disease Management II Sep-12-2011

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