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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 11

Device Problems
Other (for use when an appropriate device code cannot be identified) 4637
No Known Device Problem 3355
Battery issue 1946
Connection issue 914
Device stops intermittently 831
Power source issue 626
Infusion or flow issue 484
Device operates differently than expected 460
Pumping issue 380
High Readings 349
Break 338
Decreased pump speed 307
Foreign material present in device 252
Pumping stopped 221
Obstruction within device 164
Device alarm system issue 159
No Information 141
Electrical shorting 127
Use of Device Issue 113
Contamination during use 107
Device displays error message 105
Disconnection 92
Loss of power 90
Not audible alarm 89
Malposition of device 86
Loose or intermittent connection 74
Communication or transmission issue 70
Electrical issue 61
Occlusion within device 54
Malfunction 52
Maintenance does not comply to manufacturers recommendations 50
Increased pump speed 49
Overheating of device or device component 46
Device Issue 46
Output issue 44
Torn material 43
Blockage within device or device component 43
Bent 42
Premature discharge of battery 41
Kinked 41
No display or display failure 41
Image display error 34
Low audible alarm 34
Noise, Audible 32
Failure to power-up 30
Cut in material 30
Material deformation 27
Circuit Failure 27
Detachment of device component 26
Vibration 23
Migration of device or device component 22
Air leak 20
Improper flow or infusion 20
Data Issue 18
Device inoperable 16
Alarm not visible 15
Leak 15
Low battery 13
Poor quality image 12
Fracture 12
Device or device component damaged by another device 11
Naturally worn 11
No code available 10
Improper or incorrect procedure or method 10
Hole in material 10
Failure to pump 10
Temperature issue 9
Material integrity issue 8
Material twisted 8
Electro-static discharge 7
Failure to charge 7
Power Conditioning Issue 6
Material separation 6
Low readings 6
Insufficient flow or underinfusion 6
Patient-device incompatibility 6
No flow 6
Difficult to open or close 5
Dislodged or dislocated 5
Improper alarm 5
Detachment of device or device component 4
Charging issue 4
Fitting problem 4
Smoking 4
Incorrect display 4
Mechanical issue 4
Decoupling 4
Degraded 3
Failure to Adhere or Bond 3
Fluid leak 3
Peeled 3
Self-activation or keying 3
Dull 3
Failure to cut 3
Human-Device Interface Issue 3
Positioning Issue 3
Device handling issue 3
Unintended movement 2
Incorrect device or component shipped 2
Output below specifications 2
Total Device Problems 17812

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 3 0 0 1 0 1 0 2 5 0
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 II Jun-26-2015
7 HeartWare Inc I Jun-13-2015
8 HeartWare Inc I Jun-11-2015
9 HeartWare Inc II Jun-10-2015
10 HeartWare Inc I Jun-08-2015
11 HeartWare Inc I May-14-2015
12 HeartWare Inc I Feb-25-2015
13 HeartWare Inc II May-14-2014
14 HeartWare Inc I Apr-23-2014
15 HeartWare Inc II Jul-29-2013
16 Heartware Inc II May-14-2013
17 Thoratec Corp II Nov-24-2009
18 Thoratec Corp II Dec-22-2008
19 Thoratec Corp I Nov-21-2007
20 Thoratec Corp I Jul-27-2007
21 Thoratec Corp I Jul-27-2007
22 Thoratec Corp II Feb-10-2007
23 Thoratec Corp II Oct-13-2010
24 Thoratec Corporation I Mar-21-2014
25 Thoratec Corporation I Mar-23-2012

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