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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
Device alarm system issue 405
Fluid leak 396
Device operates differently than expected 367
Device displays error message 252
Difficult to insert 207
Inflation issue 187
Gas leak 179
Leak 146
Pumping stopped 132
Component incompatible 126
Alarm, audible 109
Kinked 85
Low battery 78
Unable to obtain readings 74
Failure to advance 72
Inadequate user interface 68
No display or display failure 67
Material rupture 64
Vacuum, loss of 61
Difficult to remove 53
Incorrect display 50
Failure to zero 43
Other (for use when an appropriate device code cannot be identified) 41
No Known Device Problem 39
Physical resistance 36
Occlusion within device 36
Communication or transmission issue 34
Blood in tubing 33
Crack 30
Aspiration issue 28
Not audible alarm 27
Image display error 24
Failure to pump 24
Device sensing issue 24
Use of Device Issue 23
Erratic display 22
Failure to run on AC/DC 20
Balloon rupture 20
Connection issue 20
Break 17
Misconnection 17
Loose or intermittent connection 16
No device output 15
Pre or post-pumping problem 15
Entrapment of device or device component 14
Not Applicable 14
Battery issue 13
Failure to sense 13
Volume accuracy issue 13
Device contamination with blood or blood product 12
Detachment of device component 12
Balloon leak(s) 12
Low audible alarm 12
Failure to calibrate 11
Air leak 10
Pumping issue 10
Foreign material present in device 9
Calibration issue 9
Difficult to advance 9
Decoupling 9
Material puncture 9
Device inoperable 8
Unraveled material 8
Difficult to flush 8
Fracture 8
Improper gas output 8
Power source issue 8
Output issue 7
Connection error 7
Material separation 7
Migration of device or device component 7
Loss of power 7
Failure to run on portable mode 6
Device emits odor 6
Failure to select signal 6
Smoking 6
Invalid sensing 6
Difficult to interrogate 6
Bent 6
Bleed back 6
Device handling issue 6
Noise, Audible 6
Detachment of device or device component 6
Electrical shorting 5
Human-Device Interface Issue 5
Premature discharge of battery 5
Component(s), broken 5
Improper or incorrect procedure or method 5
Difficult to position 5
Failure to power-up 4
Malfunction 4
Inaccurate synchronization 4
Circuit Failure 4
Blockage within device or device component 4
Hole in material 4
Electrical issue 4
Torn material 4
Malposition of device 4
Defective component 4
Total Device Problems 4843

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 1
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 III Sep-03-2014
10 Datascope Corporation II Jun-21-2010
11 Datascope Corporation II Apr-15-2009
12 Maquet Cardiovascular, LLC II Jan-09-2013
13 Maquet Datascope Corp - Cardiac Assist Division II Mar-25-2016
14 Maquet Datascope Corp - Cardiac Assist Division II Feb-23-2015
15 Maquet Datascope Corp - Cardiac Assist Division II Feb-07-2015
16 Maquet Datascope Corp - Cardiac Assist Division I May-21-2014

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