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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, flow directed
Regulation Description Flow-directed catheter.
Product CodeDYG
Regulation Number 870.1240
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 8
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
HARMAC MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to pace or properly pace 133
Inflation issue 121
Measurements, inaccurate 107
Balloon leak(s) 89
Deflation issue 77
Material rupture 60
Fluid leak 53
Incorrect or inadequate result 38
Other (for use when an appropriate device code cannot be identified) 35
Incorrect measurement 35
Balloon rupture 33
Break 31
Leak 26
Unable to obtain readings 21
Air leak 20
Contamination during use 19
No code available 18
Detachment of device component 17
Burst 15
Unknown (for use when the device problem is not known) 15
Low readings 15
No Known Device Problem 13
Incorrect display 12
Balloon burst 11
Difficult to remove 11
Component missing 9
High Readings 8
Device operates differently than expected 8
Source, detachment from 8
Difficult to insert 7
Interlumen communication 6
Hole in material 6
Kinked 5
Foreign material present in device 5
Cut in material 5
Failure to sterilize 4
Gas leak 4
Difficult to position 4
Crack 4
Deflation due to damage from surgical instrument 4
No display or display failure 3
Deflation, cause unknown 3
Difficult to flush 3
False reading from device non-compliance 3
Foreign material 3
Material fragmentation 3
Component(s), broken 3
Bleed back 3
Balloon asymmetrical 3
Unsealed device packaging 3
No device output 3
Detachment of device or device component 3
Material perforation 3
Blood in tubing 3
Defective component 3
Electrical wires, defective 2
Device Issue 2
Pressure, insufficient 2
Tubing, incorrect placement of 2
Device damaged prior to use 2
Tip breakage 2
Unstable 2
Use of Device Issue 2
Wedge, difficult to 2
Wavelength, incorrect 2
Output issue 2
Positioning Issue 2
Material integrity issue 2
Defective item 2
Occlusion within device 2
Misassembled 2
Looping 2
Plugged 2
Material puncture 2
Sterility 2
Failure to sense 2
Material separation 2
Failure to read input signal 2
Rupture, cause unknown 2
Material frayed 2
Entrapment of device or device component 2
Error or warning message, failure to produce 1
Drift 1
Fracture 1
Filter leak(s) 1
Inaccurate flowrate 1
Failure to flush 1
Bent 1
Changes in ambient temperature in device environment 1
Aspiration, excessive 1
Blockage within device or device component 1
Burn of device or device component 1
Coiled 1
Rupture, fold or crease due to 1
Premature deployment 1
Particulates 1
Pacing inadequately 1
Loose 1
Markings unclear 1
Knotted 1
Total Device Problems 1228

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

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Apr-04-2013
2 B. Braun Medical, Inc. II Jul-23-2007
3 Edwards Lifesciences Technology SARL II Jan-05-2007
4 Edwards Lifesciences, LLC II Jun-02-2015
5 Edwards Lifesciences, LLC II Aug-12-2012
6 Edwards Lifesciences, Llc II Apr-17-2009

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