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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 2017
7 5 9 12 4 20 36 30 24 37 0

Device Problems
No Known Device Problem 5034
Other (for use when an appropriate device code cannot be identified) 4637
Battery issue 2111
Connection issue 1323
Device stops intermittently 1239
Power source issue 880
Loose or intermittent connection 764
Infusion or flow issue 707
Pumping issue 666
High Readings 593
Break 503
Device operates differently than expected 473
Decreased pump speed 427
Foreign material present in device 300
Pumping stopped 296
Obstruction within device 250
Electrical shorting 244
Device alarm system issue 229
No Information 186
Not audible alarm 183
Use of Device Issue 148
Disconnection 127
Contamination during use 126
Device displays error message 126
Loss of power 119
Malposition of device 105
Overheating of device or device component 92
Communication or transmission issue 85
No display or display failure 83
Electrical issue 71
Occlusion within device 70
Image display error 67
Blockage within device or device component 67
Maintenance does not comply to manufacturers recommendations 62
Increased pump speed 58
Output issue 56
Malfunction 52
Bent 50
Torn material 50
Kinked 47
Device Issue 47
Low audible alarm 45
Cut in material 44
Premature discharge of battery 41
Detachment of device component 37
Material deformation 36
Noise, Audible 35
Migration of device or device component 34
Circuit Failure 33
Improper flow or infusion 32
Failure to power-up 31
Data Issue 28
Leak 26
Vibration 25
Device inoperable 22
Air leak 21
Protective measure issue 21
Naturally worn 19
Alarm not visible 19
Low readings 18
Failure to pump 17
Fracture 17
Poor quality image 17
Hole in material 15
Low battery 15
No code available 14
Temperature issue 13
Device or device component damaged by another device 13
Dislodged or dislocated 12
Improper or incorrect procedure or method 10
Mechanical issue 10
Incorrect display 9
Human-Device Interface Issue 9
Difficult to open or close 9
Material integrity issue 8
Material twisted 8
Issue with displayed error message 8
Failure to charge 8
Detachment of device or device component 8
Patient-device incompatibility 7
Electro-static discharge 7
Insufficient flow or underinfusion 7
Material separation 7
Particulates 7
No flow 7
Device handling issue 6
Restricted flowrate 6
Crack 6
Power Conditioning Issue 6
Increase in suction 5
Charging issue 5
Moisture damage 5
Improper alarm 5
Positioning Issue 4
Problem with software installation 4
Decoupling 4
Degraded 4
Fitting problem 4
Smoking 4
Self-activation or keying 3
Total Device Problems 23653

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 3 0 0 1 0 1 0 2 5 3 0
Class II 2 1 3 1 0 0 3 1 2 0 0
Class III 0 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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