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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
7 5 9 12 4 20 36 30 24 31

Device Problems
Other (for use when an appropriate device code cannot be identified) 4637
No Known Device Problem 4485
Battery issue 2047
Connection issue 1215
Device stops intermittently 1100
Power source issue 811
Pumping issue 589
Infusion or flow issue 565
High Readings 514
Loose or intermittent connection 490
Device operates differently than expected 469
Break 421
Decreased pump speed 381
Foreign material present in device 287
Pumping stopped 273
Electrical shorting 223
Device alarm system issue 219
Obstruction within device 211
No Information 179
Not audible alarm 170
Use of Device Issue 138
Contamination during use 123
Disconnection 122
Device displays error message 121
Loss of power 115
Malposition of device 95
Overheating of device or device component 85
Communication or transmission issue 78
No display or display failure 69
Electrical issue 69
Occlusion within device 63
Blockage within device or device component 60
Image display error 59
Maintenance does not comply to manufacturers recommendations 58
Increased pump speed 56
Malfunction 52
Output issue 52
Torn material 48
Bent 48
Device Issue 46
Kinked 45
Premature discharge of battery 41
Cut in material 41
Low audible alarm 39
Detachment of device component 33
Noise, Audible 33
Material deformation 33
Improper flow or infusion 32
Circuit Failure 30
Failure to power-up 30
Migration of device or device component 29
Vibration 25
Data Issue 25
Leak 22
Air leak 21
Device inoperable 19
Alarm not visible 17
Poor quality image 16
Fracture 15
Low battery 14
No code available 14
Naturally worn 14
Temperature issue 13
Device or device component damaged by another device 13
Hole in material 13
Low readings 11
Dislodged or dislocated 11
Improper or incorrect procedure or method 10
Failure to pump 10
Mechanical issue 10
Failure to charge 8
Difficult to open or close 8
Material integrity issue 8
Material twisted 8
Issue with displayed error message 8
No flow 7
Patient-device incompatibility 7
Electro-static discharge 7
Insufficient flow or underinfusion 7
Material separation 7
Detachment of device or device component 6
Incorrect display 6
Power Conditioning Issue 6
Device handling issue 6
Improper alarm 5
Crack 5
Charging issue 5
Smoking 4
Fitting problem 4
Decoupling 4
Degraded 4
Particulates 4
Moisture damage 4
Human-Device Interface Issue 4
Positioning Issue 4
Problem with software installation 4
Material frayed 3
Erratic display 3
Fluid leak 3
Peeled 3
Total Device Problems 21684

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 3 0 0 1 0 1 0 2 5 3
Class II 2 1 3 1 0 0 3 1 2 0
Class III 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 Inc II May-14-2013
20 Thoratec Corp II Nov-24-2009
21 Thoratec Corp II Dec-22-2008
22 Thoratec Corp I Nov-21-2007
23 Thoratec Corp I Jul-27-2007
24 Thoratec Corp I Jul-27-2007
25 Thoratec Corp II Feb-10-2007
26 Thoratec Corp II Oct-13-2010
27 Thoratec Corporation I Mar-21-2014
28 Thoratec Corporation I Mar-23-2012

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