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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 9

Device Problems
No Known Device Problem 5837
Other (for use when an appropriate device code cannot be identified) 4637
Battery issue 2252
Device stops intermittently 1426
Connection issue 1424
Loose or intermittent connection 1059
Power source issue 992
Infusion or flow issue 885
Pumping issue 792
High Readings 712
Break 675
Device operates differently than expected 475
Decreased pump speed 461
Obstruction within device 342
Pumping stopped 321
Foreign material present in device 301
Electrical shorting 276
Device alarm system issue 235
No Information 211
Not audible alarm 191
Use of Device Issue 161
Device displays error message 139
Disconnection 139
Contamination during use 127
Loss of power 119
Malposition of device 118
No display or display failure 100
Overheating of device or device component 98
Blockage within device or device component 91
Communication or transmission issue 85
Occlusion within device 80
Electrical issue 80
Image display error 69
Maintenance does not comply to manufacturers recommendations 68
Material integrity issue 62
Output issue 60
Increased pump speed 58
Material deformation 57
Protective measure issue 55
Kinked 55
Bent 54
Malfunction 52
Torn material 52
Cut in material 51
Device Issue 47
Low audible alarm 47
Restricted flowrate 46
Premature discharge of battery 41
Detachment of device component 38
Migration of device or device component 38
Noise, Audible 37
Data Issue 33
Improper flow or infusion 33
Circuit Failure 33
Failure to power-up 33
Leak 29
Device inoperable 27
Vibration 25
Air leak 22
Naturally worn 21
Failure to pump 20
Alarm not visible 19
Poor quality image 18
Low readings 18
Fracture 17
Hole in material 16
Low battery 15
No code available 14
Temperature issue 13
Dislodged or dislocated 13
Device or device component damaged by another device 13
Incorrect display 12
Crack 12
Mechanical issue 10
Improper or incorrect procedure or method 10
Insufficient flow or underinfusion 9
Difficult to open or close 9
Human-Device Interface Issue 9
Issue with displayed error message 9
Material twisted 9
No flow 8
Detachment of device or device component 8
Patient-device incompatibility 8
Material separation 8
Failure to charge 8
Particulates 7
Electro-static discharge 7
Increase in suction 7
Date-related software issue 7
Improper alarm 7
Device handling issue 6
Charging issue 6
Fitting problem 6
Power Conditioning Issue 6
Moisture damage 6
Degraded 5
False alarm 5
Smoking 5
Problem with software installation 5
Positioning Issue 4
Total Device Problems 26478

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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