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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 138
Inflation issue 121
Measurements, inaccurate 107
Balloon leak(s) 89
Deflation issue 78
Material rupture 61
Fluid leak 53
Incorrect or inadequate result 48
Other (for use when an appropriate device code cannot be identified) 35
Incorrect measurement 35
Balloon rupture 33
Break 31
Leak 27
No code available 24
Unable to obtain readings 21
Air leak 20
Contamination during use 19
Detachment of device component 18
No Known Device Problem 16
Unknown (for use when the device problem is not known) 15
Low readings 15
Burst 15
Incorrect display 12
Difficult to remove 11
Balloon burst 11
Component missing 9
High Readings 8
Device operates differently than expected 8
Source, detachment from 8
Difficult to insert 7
Hole in material 6
Interlumen communication 6
Foreign material present in device 5
Kinked 5
Cut in material 5
Difficult to position 4
Crack 4
Deflation due to damage from surgical instrument 4
Failure to sterilize 4
Gas leak 4
False reading from device non-compliance 3
Foreign material 3
Blood in tubing 3
Defective component 3
No display or display failure 3
Difficult to flush 3
Occlusion within device 3
Bleed back 3
Balloon asymmetrical 3
No device output 3
Component(s), broken 3
Material perforation 3
Detachment of device or device component 3
Deflation, cause unknown 3
Unsealed device packaging 3
Material fragmentation 3
Electrical wires, defective 2
Material separation 2
Plugged 2
Device Issue 2
Knotted 2
Positioning Issue 2
Entrapment of device or device component 2
Wedge, difficult to 2
Device damaged prior to use 2
Rupture, cause unknown 2
Wavelength, incorrect 2
Defective item 2
Tubing, incorrect placement of 2
Output issue 2
Material frayed 2
Pressure, insufficient 2
Misassembled 2
Looping 2
Use of Device Issue 2
Material puncture 2
Tip breakage 2
Material integrity issue 2
Failure to read input signal 2
Unstable 2
Sterility 2
Failure to sense 2
Aspiration, excessive 1
Drift 1
Fracture 1
Communication or transmission issue 1
Bent 1
Pacing inadequately 1
Patient-device incompatibility 1
Changes in ambient temperature in device environment 1
Markings unclear 1
Inaccurate flowrate 1
Device sensing issue 1
Rupture, fold or crease due to 1
Improper or incorrect procedure or method 1
Failure to advance 1
Unexpected therapeutic results 1
Mislabeled 1
Particulates 1
Deployment issue 1
Total Device Problems 1258

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