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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventricular (assist) bypass
Definition Approved pma: P870072
Product CodeDSQ
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
24 37 36 35 34 30

Device Problems
Adverse Event Without Identified Device or Use Problem 27030
Battery Problem 5130
Power Problem 4776
Pumping Problem 3895
Connection Problem 2984
Break 2870
Infusion or Flow Problem 1896
Pumping Stopped 1798
Device Stops Intermittently 1757
Material Integrity Problem 1349
Loose or Intermittent Connection 1274
Obstruction of Flow 1226
High Readings 1128
Decreased Pump Speed 749
Mechanical Problem 641
Material Twisted / Bent 576
Controller 548
Material Deformation 521
Disconnection 483
Electrical /Electronic Property Problem 456
Insufficient Information 441
Device Displays Incorrect Message 418
Material Split, Cut or Torn 418
Use of Device Problem 374
Electrical Shorting 325
Device Contamination with Chemical or Other Material 310
Device Alarm System 276
Complete Loss of power 268
No Audible Alarm 262
Battery 261
Loss of Power 256
Malposition of device 247
Partial Blockage 238
Electrical Power Problem 217
Device Operates Differently Than Expected 204
Communication or Transmission Problem 204
Naturally Worn 200
Appropriate Term/Code Not Available 198
Restricted Flow rate 181
Output Problem 180
Contamination During Use 176
Protective Measures Problem 176
Overheating of Device 172
Pump 172
No Display / Image 146
Data Problem 124
Device Inoperable 118
Date/Time-Related Software Problem 116
Increase in Suction 116
Noise, Audible 112
Leak / Splash 102
Kinked 93
Maintenance Does Not Comply To Manufacturers Recommendations 85
Torn Material 81
Bent 80
Display or Visual Feedback Problem 78
Crack 73
Image Display Error / Artifact 72
Low Readings 66
Low Audible Alarm 63
Cut In Material 63
Increased Pump Speed 60
Migration or Expulsion of Device 55
Cable 53
Insufficient Flow or Under Infusion 50
Failure to Pump 49
Occlusion Within Device 49
Device Difficult to Setup or Prepare 45
Incomplete or Inadequate Connection 44
Vibration 44
Improper Flow or Infusion 38
Detachment of Device or device Component 36
Circuit Failure 33
Detachment Of Device Component 30
Material Separation 29
Alarm 29
Device Damaged Prior to Use 28
Fluid Leak 28
Poor Quality Image 27
Deformation Due to Compressive Stress 26
Fitting Problem 24
Improper or Incorrect Procedure or Method 23
Fracture 23
Difficult to Remove 22
Alarm Not Visible 22
Electromagnetic Interference 22
Device Misassembled During Manufacturing / Shipping 21
Moisture Damage 20
Device Issue 20
Device Fell 20
Failure to Power Up 20
Connector Pin 19
Material Protrusion / Extrusion 19
Particulates 18
Failure to Charge 18
Hole In Material 17
Material Discolored 17
Temperature Problem 17
Electro-Static Discharge 17
Connector 17
Total Device Problems 69998

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 HeartWare Inc II Jun-26-2015
3 HeartWare Inc I Jun-13-2015
4 HeartWare Inc I Jun-11-2015
5 HeartWare Inc II Jun-10-2015
6 HeartWare Inc I Jun-08-2015
7 HeartWare Inc I May-14-2015
8 HeartWare Inc I Feb-25-2015
9 HeartWare, Inc I Oct-13-2016
10 Heartware I May-21-2018
11 Heartware I Apr-27-2017
12 Heartware I Apr-25-2017
13 Heartware, Inc. I May-22-2020
14 Heartware, Inc. I Mar-09-2020
15 Heartware, Inc. II Dec-07-2018
16 Heartware, Inc. II Oct-03-2018
17 Heartware, Inc. I Oct-17-2016
18 Heartware, Inc. I Jul-08-2016
19 Jarvik Heart Inc II Dec-18-2018
20 Thoratec Corp. II Dec-27-2019
21 Thoratec Corp. II Aug-22-2019
22 Thoratec Corp. II Apr-19-2019
23 Thoratec Corporation I May-24-2017

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