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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
ANGIODYNAMICS, 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 8
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 20
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 7
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 44
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 8
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 21
SORIN
  SUBSTANTIALLY EQUIVALENT 2
STOCKERT GMBH
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 2
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 2
VASCUTEK LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 124
Fluid leak 66
No Known Device Problem 60
Difficult to remove 49
Other (for use when an appropriate device code cannot be identified) 47
Detachment of device component 44
Break 42
Fracture 39
Material rupture 34
Kinked 27
Disconnection 25
Balloon rupture 24
Device operates differently than expected 22
Material separation 21
Difficult to insert 19
Misassembled 18
Balloon burst 18
Balloon leak(s) 18
Device misassembled during manufacturing or shipping 17
Material integrity issue 17
Tip breakage 16
Crack 15
Performance 15
No Information 15
Nonstandard device or device component 14
Particulates 12
Blockage within device or device component 12
Replace 12
Tears, rips, holes in device, device material 11
Dislodged or dislocated 11
Component(s), broken 11
Loose or intermittent connection 11
No code available 11
Migration of device or device component 10
Air leak 10
Tear, rip or hole in device packaging 10
Defective item 10
Recannulation 10
Connection issue 9
Collapse 9
Loss of or failure to bond 9
Restricted flowrate 8
Balloon pinhole 8
Split 8
Device Issue 7
Manufacturing or shipping issue associated with device 7
Misconnection 7
Occlusion within device 6
Foreign material 6
Connection error 6
Detachment of device or device component 6
Malfunction 6
Tube(s), splitting of 6
Use of Device Issue 6
Defective component 6
Sticking 5
Product quality issue 5
Bent 5
Burst 4
Material fragmentation 4
Delivered as unsterile product 4
Increase in pressure 4
Source, detachment from 4
Insufficient flow or underinfusion 4
Fitting problem 4
Cut in material 4
Device markings issue 4
Material deformation 4
Foreign material present in device 4
Improper flow or infusion 3
Device packaging compromised 3
Device, removal of (non-implant) 3
Malposition of device 3
Cannula Guide Issue, No Description 3
Device or device fragments location unknown 3
Improper or incorrect procedure or method 3
Component missing 3
Unknown (for use when the device problem is not known) 3
Material perforation 3
Device, or device fragments remain in patient 3
Size incorrect for patient 3
Difficult to position 3
Inaccurate flowrate 3
Inflation issue 3
Device clogged 3
Deflation issue 3
Infusion or flow issue 3
No flow 3
Positioning Issue 2
Torn material 2
Device handling issue 2
Difficult to deploy 2
Entrapment of device or device component 2
Material erosion 2
Component falling 2
Component incompatible 2
Decrease in suction 2
Bubble(s) 2
Failure to Adhere or Bond 2
Balloon asymmetrical 2
Total Device Problems 1207

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 1 0 1 0 1 0 0
Class II 2 2 4 3 4 7 12 6 5 3 0
Class III 1 1 0 0 0 0 0 0 0 2 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 Dec-09-2015
8 Edwards Lifesciences, LLC II Apr-02-2015
9 Edwards Lifesciences, LLC II Nov-14-2014
10 Edwards Lifesciences, LLC II Apr-16-2014
11 Edwards Lifesciences, LLC II Nov-01-2013
12 Edwards Lifesciences, LLC I Oct-31-2013
13 Edwards Lifesciences, LLC II Aug-14-2013
14 Edwards Lifesciences, LLC II Aug-14-2013
15 Edwards Lifesciences, LLC II Jul-17-2013
16 Edwards Lifesciences, LLC II May-14-2013
17 Edwards Lifesciences, LLC II Apr-14-2013
18 Edwards Lifesciences, LLC II Jul-09-2012
19 Edwards Lifesciences, LLC II Jul-11-2011
20 Maquet Cardiovascular II Aug-31-2009
21 Maquet Cardiovascular Us Sales, Llc II Feb-20-2013
22 Medtronic Cardiovascular Revascularization & Surgical Therap II Jan-26-2009
23 Medtronic Inc. Cardiac Rhythm Disease Management II Feb-20-2014
24 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-27-2013
25 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-05-2013
26 Medtronic Inc. Cardiac Rhythm Disease Management II Dec-28-2012
27 Medtronic Inc. Cardiac Rhythm Disease Management II Jan-18-2012
28 Medtronic Perfusion Systems III Feb-26-2016
29 Medtronic Perfusion Systems II Nov-12-2015
30 Medtronic Perfusion Systems II Aug-19-2015
31 Medtronic Perfusion Systems II Jun-26-2015
32 Medtronic Perfusion Systems II Jul-24-2008
33 OriGen Biomedical, Inc. I Apr-23-2015
34 Sorin Group USA, Inc. II Sep-08-2016
35 Sorin Group USA, Inc. II Jul-08-2016
36 Sorin Group USA, Inc. III Feb-25-2016
37 Sorin Group USA, Inc. II Feb-16-2016
38 Sorin Group USA, Inc. II Aug-20-2013
39 Sorin Group USA, Inc. II Nov-15-2010
40 Sorin Group USA, Inc. II Jul-22-2010
41 Sorin Group USA, Inc. II Mar-12-2010
42 Surge Medical Solutions, LLC II Jun-06-2007
43 Terumo Cardiovascular Systems Corp II Oct-31-2014
44 Terumo Cardiovascular Systems Corp II Jul-10-2007
45 Terumo Cardiovascular Systems Corp III Feb-27-2007
46 Terumo Cardiovascular Systems Corporation II Jul-23-2014
47 Terumo Cardiovascular Systems Corporation II Mar-19-2014
48 Terumo Cardiovascular Systems Corporation II Nov-08-2013
49 Terumo Cardiovascular Systems Corporation II Jan-11-2013
50 Terumo Cardiovascular Systems Corporation II Dec-03-2012
51 Terumo Cardiovascular Systems Corporation II Jun-27-2012
52 Terumo Cardiovascular Systems Corporation II Jun-20-2012
53 Terumo Cardiovascular Systems Corporation II Mar-23-2012
54 Terumo Cardiovascular Systems Corporation I Jun-14-2011
55 Terumo Cardiovascular Systems Corporation II Feb-06-2009

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