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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 22

Device Problems
Other (for use when an appropriate device code cannot be identified) 4637
No Known Device Problem 3812
Battery issue 1990
Connection issue 1076
Device stops intermittently 967
Power source issue 700
Infusion or flow issue 527
Pumping issue 492
Device operates differently than expected 465
High Readings 425
Break 367
Decreased pump speed 349
Foreign material present in device 271
Loose or intermittent connection 259
Pumping stopped 246
Electrical shorting 191
Device alarm system issue 188
Obstruction within device 170
No Information 156
Not audible alarm 137
Use of Device Issue 128
Contamination during use 119
Device displays error message 116
Disconnection 114
Loss of power 104
Malposition of device 92
Communication or transmission issue 75
Overheating of device or device component 68
Electrical issue 62
Occlusion within device 60
Image display error 55
Maintenance does not comply to manufacturers recommendations 54
No display or display failure 53
Increased pump speed 52
Malfunction 52
Blockage within device or device component 51
Output issue 47
Torn material 47
Device Issue 46
Kinked 44
Bent 42
Premature discharge of battery 41
Low audible alarm 38
Cut in material 36
Noise, Audible 32
Improper flow or infusion 30
Detachment of device component 30
Failure to power-up 30
Circuit Failure 28
Material deformation 28
Migration of device or device component 27
Vibration 24
Data Issue 22
Air leak 20
Leak 18
Poor quality image 16
Alarm not visible 16
Device inoperable 16
Fracture 14
Low battery 13
Device or device component damaged by another device 13
Naturally worn 13
Temperature issue 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 8
Dislodged or dislocated 7
Electro-static discharge 7
Material separation 7
Failure to charge 7
No flow 7
Incorrect display 6
Power Conditioning Issue 6
Insufficient flow or underinfusion 6
Detachment of device or device component 6
Patient-device incompatibility 6
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
Material frayed 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
Total Device Problems 19626

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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