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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 19

Device Problems
Other (for use when an appropriate device code cannot be identified) 4637
No Known Device Problem 3489
Battery issue 1960
Connection issue 952
Device stops intermittently 878
Power source issue 638
Infusion or flow issue 498
Device operates differently than expected 460
Pumping issue 399
High Readings 372
Break 342
Decreased pump speed 317
Foreign material present in device 257
Pumping stopped 229
Obstruction within device 168
Device alarm system issue 162
Electrical shorting 152
No Information 145
Use of Device Issue 115
Contamination during use 108
Device displays error message 106
Disconnection 105
Not audible alarm 105
Loss of power 91
Malposition of device 87
Loose or intermittent connection 81
Communication or transmission issue 72
Electrical issue 61
Occlusion within device 59
Overheating of device or device component 53
Malfunction 52
Maintenance does not comply to manufacturers recommendations 52
Increased pump speed 51
Image display error 48
Blockage within device or device component 46
Device Issue 46
Torn material 44
Output issue 44
No display or display failure 43
Kinked 42
Bent 42
Premature discharge of battery 41
Low audible alarm 36
Cut in material 33
Noise, Audible 32
Failure to power-up 30
Material deformation 28
Circuit Failure 27
Detachment of device component 26
Migration of device or device component 25
Vibration 23
Improper flow or infusion 20
Air leak 20
Data Issue 19
Device inoperable 16
Alarm not visible 15
Poor quality image 15
Leak 15
Fracture 13
Low battery 13
Device or device component damaged by another device 13
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
Dislodged or dislocated 7
Electro-static discharge 7
Material separation 7
Low readings 7
Failure to charge 7
Power Conditioning Issue 6
Insufficient flow or underinfusion 6
Difficult to open or close 6
Patient-device incompatibility 6
No flow 6
Improper alarm 5
Incorrect display 5
Mechanical issue 4
Decoupling 4
Detachment of device or device component 4
Charging issue 4
Fitting problem 4
Smoking 4
Dull 3
Failure to cut 3
Human-Device Interface Issue 3
Degraded 3
Failure to Adhere or Bond 3
Fluid leak 3
Peeled 3
Self-activation or keying 3
Positioning Issue 3
Device handling issue 3
Unintended movement 2
Incorrect device or component shipped 2
Output below specifications 2
Total Device Problems 18279

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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