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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 21

Device Problems
Other (for use when an appropriate device code cannot be identified) 4637
No Known Device Problem 3651
Battery issue 1988
Connection issue 1025
Device stops intermittently 922
Power source issue 664
Infusion or flow issue 508
Device operates differently than expected 465
Pumping issue 441
High Readings 399
Break 352
Decreased pump speed 329
Foreign material present in device 268
Pumping stopped 239
Loose or intermittent connection 201
Device alarm system issue 176
Electrical shorting 176
Obstruction within device 169
No Information 154
Use of Device Issue 122
Not audible alarm 120
Contamination during use 116
Disconnection 108
Device displays error message 108
Loss of power 100
Malposition of device 90
Communication or transmission issue 74
Overheating of device or device component 63
Electrical issue 61
Occlusion within device 59
Image display error 53
Maintenance does not comply to manufacturers recommendations 53
Increased pump speed 52
Malfunction 52
No display or display failure 50
Blockage within device or device component 49
Device Issue 46
Output issue 46
Torn material 45
Kinked 43
Bent 42
Premature discharge of battery 41
Low audible alarm 37
Cut in material 34
Noise, Audible 32
Detachment of device component 30
Failure to power-up 30
Improper flow or infusion 29
Material deformation 28
Migration of device or device component 27
Circuit Failure 27
Vibration 24
Data Issue 21
Air leak 20
Leak 17
Poor quality image 16
Alarm not visible 16
Device inoperable 16
Low battery 13
Device or device component damaged by another device 13
Fracture 13
Temperature issue 12
Naturally worn 12
Hole in material 11
Failure to pump 10
Improper or incorrect procedure or method 10
No code available 10
Low readings 9
Material integrity issue 8
Material twisted 8
Difficult to open or close 7
Dislodged or dislocated 7
Electro-static discharge 7
Material separation 7
Failure to charge 7
Incorrect display 6
Power Conditioning Issue 6
Insufficient flow or underinfusion 6
Patient-device incompatibility 6
No flow 6
Detachment of device or device component 5
Improper alarm 5
Charging issue 4
Fitting problem 4
Smoking 4
Mechanical issue 4
Decoupling 4
Degraded 3
Erratic display 3
Failure to Adhere or Bond 3
Moisture damage 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
Total Device Problems 19023

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

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