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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, balloon, intra-aortic and control
Regulation Description Intra-aortic balloon and control system.
Product CodeDSP
Regulation Number 870.3535
Device Class 2


Premarket Reviews
ManufacturerDecision
ABIOMED
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 16
BELMONT INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 14
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
DATASCOPE CORP.
  1
  SUBSTANTIALLY EQUIVALENT 64
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device-device incompatibility 651
Fluid leak 466
Device alarm system issue 449
Device operates differently than expected 369
Device displays error message 264
Gas leak 219
Difficult to insert 214
Inflation issue 206
Leak 156
Pumping stopped 143
Component incompatible 126
Alarm, audible 109
Kinked 93
Unable to obtain readings 86
Material rupture 83
Low battery 80
No display or display failure 74
Failure to advance 73
Inadequate user interface 69
Difficult to remove 63
Vacuum, loss of 61
Incorrect display 54
Occlusion within device 51
Failure to zero 45
Communication or transmission issue 42
Other (for use when an appropriate device code cannot be identified) 41
No Known Device Problem 39
Physical resistance 36
Blood in tubing 33
Aspiration issue 32
Crack 31
Connection issue 30
Not audible alarm 29
Failure to pump 27
Use of Device Issue 24
Erratic display 24
Image display error 24
Device sensing issue 24
Break 22
Failure to run on AC/DC 20
Balloon rupture 20
Loose or intermittent connection 19
Misconnection 18
Battery issue 18
Entrapment of device or device component 17
Volume accuracy issue 16
No device output 15
Pre or post-pumping problem 15
Failure to sense 14
Device contamination with blood or blood product 14
Detachment of device component 14
Not Applicable 14
Difficult to advance 13
Failure to calibrate 12
Balloon leak(s) 12
Low audible alarm 12
Power source issue 11
Pumping issue 10
Air leak 10
Difficult to interrogate 10
Difficult to flush 10
Material separation 10
Material puncture 9
Fracture 9
Decoupling 9
Foreign material present in device 9
Calibration issue 9
Improper gas output 8
Migration of device or device component 8
Device inoperable 8
Unraveled material 8
Loss of power 7
Hole in material 7
Connection error 7
Bleed back 7
Detachment of device or device component 7
Output issue 7
Human-Device Interface Issue 6
Low readings 6
Device handling issue 6
Noise, Audible 6
Bent 6
Failure to run on portable mode 6
Difficult to position 6
Device emits odor 6
Failure to select signal 6
Smoking 6
Invalid sensing 6
Improper or incorrect procedure or method 5
Blockage within device or device component 5
Premature discharge of battery 5
Component(s), broken 5
Electrical issue 5
Electrical shorting 5
Defective component 4
Defective item 4
Malposition of device 4
Torn material 4
No Information 4
Circuit Failure 4
Total Device Problems 5225

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 1 0 0 0 1 0 1 0
Class II 0 2 1 1 0 0 2 0 4 2 1
Class III 0 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Mar-10-2015
2 Arrow International Inc II Mar-02-2015
3 Arrow International Inc II Apr-06-2013
4 Arrow International Inc II Jan-25-2008
5 Arrow International, Inc. I Apr-16-2009
6 Arrow International, Inc., Division of Teleflex Medical Inc. I Mar-11-2016
7 Arrow International, Inc., Division of Teleflex Medical Inc. I Dec-23-2010
8 Datascope Corp II Jan-31-2008
9 Datascope Corporation II Jun-08-2016
10 Datascope Corporation III Sep-03-2014
11 Datascope Corporation II Jun-21-2010
12 Datascope Corporation II Apr-15-2009
13 Maquet Cardiovascular, LLC II Jan-09-2013
14 Maquet Datascope Corp - Cardiac Assist Division II Mar-02-2017
15 Maquet Datascope Corp - Cardiac Assist Division II Mar-25-2016
16 Maquet Datascope Corp - Cardiac Assist Division II Feb-23-2015
17 Maquet Datascope Corp - Cardiac Assist Division II Feb-07-2015
18 Maquet Datascope Corp - Cardiac Assist Division I May-21-2014

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