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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 418
Device alarm system issue 416
Device operates differently than expected 369
Device displays error message 259
Difficult to insert 212
Gas leak 200
Inflation issue 189
Leak 148
Pumping stopped 138
Component incompatible 126
Alarm, audible 109
Kinked 87
Low battery 78
Unable to obtain readings 77
Material rupture 72
Failure to advance 72
No display or display failure 70
Inadequate user interface 69
Vacuum, loss of 61
Difficult to remove 55
Incorrect display 51
Failure to zero 43
Other (for use when an appropriate device code cannot be identified) 41
Occlusion within device 40
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 26
Use of Device Issue 24
Image display error 24
Device sensing issue 24
Erratic display 22
Connection issue 21
Failure to run on AC/DC 20
Balloon rupture 20
Break 18
Misconnection 18
Loose or intermittent connection 17
Entrapment of device or device component 16
No device output 15
Pre or post-pumping problem 15
Failure to sense 14
Not Applicable 14
Battery issue 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
Pumping issue 10
Air leak 10
Decoupling 9
Material puncture 9
Calibration issue 9
Difficult to advance 9
Power source issue 9
Foreign material present in device 9
Device inoperable 8
Unraveled material 8
Difficult to interrogate 8
Difficult to flush 8
Fracture 8
Improper gas output 8
Connection error 7
Bleed back 7
Material separation 7
Migration of device or device component 7
Loss of power 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
Premature discharge of battery 5
Component(s), broken 5
Improper or incorrect procedure or method 5
Electrical shorting 5
Defective item 4
Malposition of device 4
Defective component 4
Malfunction 4
Torn material 4
Inaccurate synchronization 4
Failure to power-up 4
Total Device Problems 4970

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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