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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventricular (assisst) bypass
Definition Approved pma: P870072
Product CodeDSQ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
7 5 9 12 4 20 36 30 24 37 34

Device Problems
No Known Device Problem 6905
Other (for use when an appropriate device code cannot be identified) 4637
Battery issue 2598
Device stops intermittently 1687
Connection issue 1615
Power source issue 1249
Loose or intermittent connection 1197
Infusion or flow issue 1127
Pumping issue 981
Break 948
High Readings 889
Decreased pump speed 499
Device operates differently than expected 478
Obstruction within device 456
Pumping stopped 381
Material integrity issue 364
Electrical shorting 306
Foreign material present in device 304
No Information 253
Device alarm system issue 239
Not audible alarm 200
Use of Device Issue 177
Device displays error message 169
Disconnection 166
Protective measure issue 165
Blockage within device or device component 138
Malposition of device 137
Material deformation 133
Contamination during use 130
Loss of power 119
No display or display failure 109
Overheating of device or device component 106
Restricted flowrate 104
Electrical issue 95
Communication or transmission issue 88
Occlusion within device 83
Maintenance does not comply to manufacturers recommendations 75
Torn material 72
Kinked 71
Image display error 70
Output issue 68
Bent 62
Date-related software issue 60
Increased pump speed 58
Cut in material 56
Malfunction 52
Migration of device or device component 51
Crack 50
Low audible alarm 50
Device Issue 49
Detachment of device component 44
Noise, Audible 44
Premature discharge of battery 41
Data Issue 38
Leak 35
Circuit Failure 33
Failure to power-up 33
Improper flow or infusion 33
Device inoperable 31
Vibration 29
Failure to pump 25
Low readings 25
Air leak 23
Hole in material 22
Naturally worn 21
Fracture 20
Alarm not visible 19
Poor quality image 18
Dislodged or dislocated 16
No code available 15
Incorrect display 15
Low battery 15
Material separation 14
Device or device component damaged by another device 13
Temperature issue 13
Improper or incorrect procedure or method 11
Mechanical issue 11
Increase in suction 10
Material twisted 10
Issue with displayed error message 9
No flow 9
Human-Device Interface Issue 9
Difficult to open or close 9
Insufficient flow or underinfusion 9
Degraded 9
Material discolored 8
Failure to charge 8
Fitting problem 8
Detachment of device or device component 8
Patient-device incompatibility 8
Improper alarm 7
Electro-static discharge 7
Moisture damage 7
Particulates 7
Smoking 6
Power Conditioning Issue 6
Charging issue 6
Device handling issue 6
Positioning Issue 5
Problem with software installation 5
Total Device Problems 30909

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 3 0 0 1 0 1 0 2 5 3 3
Class II 2 1 3 1 0 0 3 1 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abiomed, Inc. I Mar-04-2010
2 Abiomed, Inc. II Sep-16-2009
3 Abiomed, Inc. II Sep-01-2009
4 Abiomed, Inc. II Mar-07-2007
5 Carestream Health Inc. II Nov-13-2013
6 HeartWare Inc I Oct-17-2016
7 HeartWare Inc I Jul-08-2016
8 HeartWare Inc II Jun-26-2015
9 HeartWare Inc I Jun-13-2015
10 HeartWare Inc I Jun-11-2015
11 HeartWare Inc II Jun-10-2015
12 HeartWare Inc I Jun-08-2015
13 HeartWare Inc I May-14-2015
14 HeartWare Inc I Feb-25-2015
15 HeartWare Inc II May-14-2014
16 HeartWare Inc I Apr-23-2014
17 HeartWare Inc II Jul-29-2013
18 HeartWare, Inc I Oct-13-2016
19 Heartware I Apr-27-2017
20 Heartware I Apr-25-2017
21 Heartware Inc II May-14-2013
22 Thoratec Corp II Nov-24-2009
23 Thoratec Corp II Dec-22-2008
24 Thoratec Corp I Nov-21-2007
25 Thoratec Corp I Jul-27-2007
26 Thoratec Corp I Jul-27-2007
27 Thoratec Corp II Feb-10-2007
28 Thoratec Corp II Oct-13-2010
29 Thoratec Corporation I May-24-2017
30 Thoratec Corporation I Mar-21-2014
31 Thoratec Corporation I Mar-23-2012

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