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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 412
Fluid leak 403
Device operates differently than expected 367
Device displays error message 252
Difficult to insert 208
Inflation issue 187
Gas leak 180
Leak 147
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 68
Material rupture 65
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
Occlusion within device 38
Physical resistance 36
Communication or transmission issue 34
Blood in tubing 33
Crack 30
Aspiration issue 29
Not audible alarm 28
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
Misconnection 18
Break 17
Loose or intermittent connection 16
No device output 15
Pre or post-pumping problem 15
Entrapment of device or device component 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
Foreign material present in device 9
Calibration issue 9
Difficult to advance 9
Power source issue 8
Device inoperable 8
Unraveled material 8
Difficult to flush 8
Fracture 8
Improper gas output 8
Difficult to interrogate 7
Connection error 7
Material separation 7
Migration of device or device component 7
Loss of power 7
Output issue 7
Device handling issue 6
Detachment of device or device component 6
Noise, Audible 6
Failure to run on portable mode 6
Device emits odor 6
Failure to select signal 6
Smoking 6
Invalid sensing 6
Bent 6
Bleed back 6
Premature discharge of battery 5
Component(s), broken 5
Hole in material 5
Improper or incorrect procedure or method 5
Difficult to position 5
Electrical shorting 5
Human-Device Interface Issue 5
Torn material 4
Malposition of device 4
Defective component 4
Low readings 4
Defective item 4
Failure to power-up 4
Malfunction 4
Inaccurate synchronization 4
Electrical issue 4
Total Device Problems 4871

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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