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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 439
Device alarm system issue 423
Device operates differently than expected 369
Device displays error message 265
Difficult to insert 212
Gas leak 209
Inflation issue 198
Leak 153
Pumping stopped 140
Component incompatible 126
Alarm, audible 109
Kinked 89
Unable to obtain readings 79
Low battery 78
Material rupture 76
No display or display failure 73
Failure to advance 72
Inadequate user interface 69
Vacuum, loss of 61
Difficult to remove 58
Incorrect display 53
Occlusion within device 46
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 31
Aspiration issue 30
Not audible alarm 28
Failure to pump 27
Use of Device Issue 24
Device sensing issue 24
Image display error 24
Erratic display 23
Connection issue 23
Balloon rupture 20
Failure to run on AC/DC 20
Break 19
Loose or intermittent connection 18
Misconnection 18
Entrapment of device or device component 17
Battery issue 16
Pre or post-pumping problem 15
No device output 15
Failure to sense 14
Not Applicable 14
Device contamination with blood or blood product 13
Volume accuracy issue 13
Detachment of device component 13
Balloon leak(s) 12
Low audible alarm 12
Power source issue 11
Failure to calibrate 11
Air leak 10
Pumping issue 10
Material separation 9
Foreign material present in device 9
Calibration issue 9
Difficult to advance 9
Material puncture 9
Difficult to flush 9
Decoupling 9
Difficult to interrogate 9
Device inoperable 8
Fracture 8
Improper gas output 8
Unraveled material 8
Bleed back 7
Migration of device or device component 7
Connection error 7
Output issue 7
Loss of power 7
Hole in material 6
Device handling issue 6
Device emits odor 6
Detachment of device or device component 6
Noise, Audible 6
Difficult to position 6
Failure to select signal 6
Human-Device Interface Issue 6
Bent 6
Low readings 6
Failure to run on portable mode 6
Invalid sensing 6
Smoking 6
Premature discharge of battery 5
Electrical issue 5
Improper or incorrect procedure or method 5
Component(s), broken 5
Electrical shorting 5
Blockage within device or device component 4
Inability to autofill 4
Failure to power-up 4
No Information 4
Torn material 4
Defective item 4
Malfunction 4
Total Device Problems 5071

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 0
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-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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