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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, cannula and tubing, vascular, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass vascular catheter, cannula, or tubing.
Product CodeDWF
Regulation Number 870.4210
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 4
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
A-MED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVALON
  SUBSTANTIALLY EQUIVALENT 2
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 6
California Medical Laboratories Inc
  SUBSTANTIALLY EQUIVALENT 7
CARDIAC ASSIST DIV.
  SUBSTANTIALLY EQUIVALENT 3
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COBE INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DMC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 19
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 11
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTER-VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOSTRA
  SUBSTANTIALLY EQUIVALENT 9
KENDALL
  SUBSTANTIALLY EQUIVALENT 11
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEVITRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 5
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 32
NOVALUNG GMBH
  SUBSTANTIALLY EQUIVALENT 1
ORIGEN BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
POLYSTAN
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 21
SORIN
  SUBSTANTIALLY EQUIVALENT 1
STOCKERT GMBH
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 2
VASCUTEK LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 91
Difficult to remove 43
Fluid leak 39
Other (for use when an appropriate device code cannot be identified) 34
Detachment of device component 32
Material rupture 30
Fracture 28
Balloon rupture 24
Break 23
Difficult to insert 19
Balloon burst 18
Balloon leak(s) 18
Disconnection 17
Kinked 15
Performance 15
Tip breakage 15
Material integrity issue 13
Replace 12
Loose or intermittent connection 11
Tears, rips, holes in device, device material 11
Recannulation 10
Defective item 9
Component(s), broken 9
Blockage within device or device component 9
Balloon pinhole 8
Crack 8
Particulates 8
Collapse 8
No Information 8
No code available 8
Material separation 8
Device Issue 7
Device operates differently than expected 6
Foreign material 6
Connection error 6
Restricted flowrate 6
Misconnection 6
Defective component 5
Misassembled 5
Split 5
Tube(s), splitting of 5
Cut in material 4
Source, detachment from 4
Air leak 4
Occlusion within device 4
Connection issue 4
Device markings issue 4
No Known Device Problem 4
Malfunction 4
Tear, rip or hole in device packaging 4
Product quality issue 4
Sticking 4
Material deformation 3
Foreign material present in device 3
Device, removal of (non-implant) 3
Device, or device fragments remain in patient 3
Use of Device Issue 3
Device or device fragments location unknown 3
Cannula Guide Issue, No Description 3
Unknown (for use when the device problem is not known) 3
Material perforation 3
Component missing 3
Failure to deliver 2
Obstruction within device 2
Tubing, incorrect placement of 2
Shipping damage or problem 2
Mechanical issue 2
Balloon asymmetrical 2
Inflation issue 2
Bent 2
Burst 2
Device clogged 2
Sharp/jagged/rough/etched/scratched 2
Flare or flash 2
Incorrect device or component shipped 2
Inaccurate flowrate 2
Improper or incorrect procedure or method 2
Fitting problem 2
Bubble(s) 2
Locking mechanism failure 2
Poor gas exchange 2
Entrapment of device or device component 2
Valve(s), sticking 2
Device damaged prior to use 2
Air eliminator, defective 1
Shaft, split 1
Unraveled material 1
Material erosion 1
Increase in pressure 1
Bleed back 1
Deflation, cause unknown 1
Difficult to deploy 1
Material Distortion 1
Mechanics altered 1
Loose 1
Contamination during use 1
Decoupling 1
Material discolored 1
Dent in material 1
Device misassembled during manufacturing or shipping 1
Total Device Problems 792

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 1 0 0
Class II 2 2 4 3 4 7 5
Class III 1 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vas II Aug-26-2009
2 Cardiac Assist, Inc II Jan-10-2011
3 Edwards Lifesciences Llc II May-13-2011
4 Edwards Lifesciences Llc II Jan-28-2011
5 Edwards Lifesciences Research Medical, Inc. III Sep-26-2008
6 Edwards Lifesciences Research Medical, Inc. II Sep-11-2008
7 Edwards Lifesciences, LLC II May-14-2013
8 Edwards Lifesciences, LLC II Apr-14-2013
9 Edwards Lifesciences, LLC II Jul-09-2012
10 Edwards Lifesciences, LLC II Jul-11-2011
11 Maquet Cardiovascular II Aug-31-2009
12 Maquet Cardiovascular Us Sales, Llc II Feb-20-2013
13 Medtronic Cardiovascular Revascularization & Surgical Therap II Jan-26-2009
14 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-05-2013
15 Medtronic Inc. Cardiac Rhythm Disease Management II Dec-28-2012
16 Medtronic Inc. Cardiac Rhythm Disease Management II Jan-18-2012
17 Medtronic Perfusion Systems II Jul-24-2008
18 Sorin Group USA, Inc. II Nov-15-2010
19 Sorin Group USA, Inc. II Jul-22-2010
20 Sorin Group USA, Inc. II Mar-12-2010
21 Surge Medical Solutions, LLC II Jun-06-2007
22 Terumo Cardiovascular Systems Corp II Jul-10-2007
23 Terumo Cardiovascular Systems Corp III Feb-27-2007
24 Terumo Cardiovascular Systems Corporation II Jan-11-2013
25 Terumo Cardiovascular Systems Corporation II Dec-03-2012
26 Terumo Cardiovascular Systems Corporation II Jun-27-2012
27 Terumo Cardiovascular Systems Corporation II Jun-20-2012
28 Terumo Cardiovascular Systems Corporation II Mar-23-2012
29 Terumo Cardiovascular Systems Corporation I Jun-14-2011
30 Terumo Cardiovascular Systems Corporation II Feb-06-2009

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