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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 4875
Other (for use when an appropriate device code cannot be identified) 4637
Battery issue 2093
Connection issue 1301
Device stops intermittently 1200
Power source issue 844
Loose or intermittent connection 676
Infusion or flow issue 650
Pumping issue 638
High Readings 567
Device operates differently than expected 472
Break 469
Decreased pump speed 411
Foreign material present in device 299
Pumping stopped 292
Obstruction within device 243
Electrical shorting 238
Device alarm system issue 227
No Information 184
Not audible alarm 175
Use of Device Issue 144
Contamination during use 126
Device displays error message 125
Disconnection 124
Loss of power 118
Malposition of device 102
Overheating of device or device component 91
Communication or transmission issue 85
No display or display failure 76
Electrical issue 70
Image display error 67
Occlusion within device 65
Blockage within device or device component 65
Maintenance does not comply to manufacturers recommendations 62
Increased pump speed 58
Output issue 55
Malfunction 52
Bent 50
Torn material 49
Device Issue 47
Kinked 46
Cut in material 44
Low audible alarm 41
Premature discharge of battery 41
Detachment of device component 37
Material deformation 35
Noise, Audible 34
Migration of device or device component 34
Circuit Failure 33
Improper flow or infusion 32
Failure to power-up 31
Data Issue 27
Vibration 25
Leak 24
Air leak 21
Device inoperable 21
Alarm not visible 19
Poor quality image 17
Fracture 16
Low readings 16
Naturally worn 16
Low battery 15
Hole in material 15
No code available 14
Temperature issue 13
Device or device component damaged by another device 13
Failure to pump 13
Dislodged or dislocated 12
Improper or incorrect procedure or method 10
Mechanical issue 10
Difficult to open or close 9
Human-Device Interface Issue 9
Issue with displayed error message 8
Material integrity issue 8
Material twisted 8
Protective measure issue 8
Failure to charge 8
Detachment of device or device component 8
Patient-device incompatibility 7
Insufficient flow or underinfusion 7
Electro-static discharge 7
Material separation 7
Incorrect display 7
No flow 7
Device handling issue 6
Power Conditioning Issue 6
Particulates 6
Moisture damage 5
Restricted flowrate 5
Crack 5
Charging issue 5
Improper alarm 5
Positioning Issue 4
Problem with software installation 4
Fitting problem 4
Smoking 4
Decoupling 4
Degraded 4
Erratic display 3
Failure to Adhere or Bond 3
Total Device Problems 23028

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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