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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 15
BELMONT INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 14
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
DATASCOPE CORP.
  1
  SUBSTANTIALLY EQUIVALENT 63
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device-device incompatibility 651
Fluid leak 431
Device alarm system issue 416
Device operates differently than expected 369
Device displays error message 264
Difficult to insert 212
Gas leak 206
Inflation issue 193
Leak 150
Pumping stopped 138
Component incompatible 126
Alarm, audible 109
Kinked 88
Low battery 78
Unable to obtain readings 77
Material rupture 75
No display or display failure 72
Failure to advance 72
Inadequate user interface 69
Vacuum, loss of 61
Difficult to remove 55
Incorrect display 52
Occlusion within device 43
Failure to zero 43
Other (for use when an appropriate device code cannot be identified) 41
No Known Device Problem 39
Physical resistance 36
Communication or transmission issue 36
Blood in tubing 33
Crack 30
Aspiration issue 29
Not audible alarm 28
Failure to pump 27
Use of Device Issue 24
Image display error 24
Device sensing issue 24
Connection issue 22
Erratic display 22
Failure to run on AC/DC 20
Balloon rupture 20
Break 18
Misconnection 18
Loose or intermittent connection 18
Entrapment of device or device component 16
No device output 15
Pre or post-pumping problem 15
Failure to sense 14
Battery issue 14
Not Applicable 14
Volume accuracy issue 13
Device contamination with blood or blood product 12
Balloon leak(s) 12
Detachment of device component 12
Low audible alarm 12
Failure to calibrate 11
Pumping issue 10
Air leak 10
Decoupling 9
Difficult to flush 9
Material puncture 9
Power source issue 9
Foreign material present in device 9
Calibration issue 9
Difficult to advance 9
Device inoperable 8
Unraveled material 8
Fracture 8
Improper gas output 8
Difficult to interrogate 8
Connection error 7
Bleed back 7
Material separation 7
Loss of power 7
Migration of device or device component 7
Output issue 7
Human-Device Interface Issue 6
Detachment of device or device component 6
Low readings 6
Device handling issue 6
Noise, Audible 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
Bent 6
Hole in material 6
Electrical issue 5
Component(s), broken 5
Premature discharge of battery 5
Improper or incorrect procedure or method 5
Electrical shorting 5
No Information 4
Malfunction 4
Defective item 4
Malposition of device 4
Torn material 4
Defective component 4
Inaccurate synchronization 4
Total Device Problems 5015

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 1 0 0 0 1 0 1
Class II 0 2 1 1 0 0 2 0 4 2
Class III 0 0 0 0 0 0 0 1 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-25-2016
15 Maquet Datascope Corp - Cardiac Assist Division II Feb-23-2015
16 Maquet Datascope Corp - Cardiac Assist Division II Feb-07-2015
17 Maquet Datascope Corp - Cardiac Assist Division I May-21-2014

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