Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device ventricular (assist) bypass
Definition Approved pma: P870072
Product CodeDSQ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
9 12 4 20 36 30 24 37 36 35 34 48 38 33 48 18

MDR Year MDR Reports MDR Events
2014 3900 3900
2015 6769 6769
2016 7187 7187
2017 9055 9055
2018 12660 12660
2019 20216 20216
2020 14238 14238
2021 15765 15765
2022 15994 15994
2023 13056 13056
2024 3085 3085

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 61104 61104
Battery Problem 9433 9433
Pumping Problem 7714 7714
Power Problem 6449 6449
Mechanical Problem 5796 5796
Infusion or Flow Problem 5270 5270
Pumping Stopped 3930 3930
Break 3903 3903
Connection Problem 3771 3771
Material Integrity Problem 2412 2412
Device Stops Intermittently 2301 2301
Disconnection 1915 1915
Obstruction of Flow 1856 1856
Electrical Power Problem 1773 1773
Insufficient Information 1732 1732
Electrical /Electronic Property Problem 1692 1692
Complete Loss of Power 1686 1686
Decreased Pump Speed 1586 1586
Loose or Intermittent Connection 1383 1383
High Readings 1357 1357
Material Twisted/Bent 1325 1325
Material Split, Cut or Torn 998 998
Material Deformation 951 951
Use of Device Problem 799 799
No Apparent Adverse Event 729 729
Communication or Transmission Problem 717 717
Device Displays Incorrect Message 688 688
Device Alarm System 556 556
Display or Visual Feedback Problem 543 543
Premature Discharge of Battery 522 522
Device Difficult to Setup or Prepare 510 510
Noise, Audible 467 467
Loss of Power 451 451
No Audible Alarm 446 446
Malposition of Device 443 443
Improper or Incorrect Procedure or Method 428 428
Device Operates Differently Than Expected 404 404
Electrical Shorting 401 401
Device Contamination with Chemical or Other Material 390 390
Overheating of Device 372 372
Increase in Suction 323 323
Appropriate Term/Code Not Available 312 312
Output Problem 281 281
Partial Blockage 271 271
No Display/Image 262 262
Failure to Power Up 261 261
Naturally Worn 253 253
Data Problem 242 242
Contamination 220 220
Failure to Charge 218 218
Failure to Pump 213 213
Protective Measures Problem 203 203
Restricted Flow rate 188 188
Leak/Splash 160 160
Date/Time-Related Software Problem 155 155
Fluid/Blood Leak 145 145
Failure to Align 143 143
Low Audible Alarm 136 136
Device Inoperable 133 133
Occlusion Within Device 130 130
Crack 128 128
Kinked 125 125
Bent 113 113
Insufficient Flow or Under Infusion 113 113
Torn Material 108 108
Detachment of Device or Device Component 106 106
Contamination /Decontamination Problem 103 103
Deformation Due to Compressive Stress 103 103
Electro-Static Discharge 100 100
Fracture 100 100
Increased Pump Speed 98 98
Alarm Not Visible 97 97
Other (for use when an appropriate device code cannot be identified) 96 96
Vibration 91 91
Electromagnetic Interference 87 87
Maintenance Does Not Comply To Manufacturers Recommendations 87 87
Display Difficult to Read 86 86
Corroded 86 86
Low Readings 84 84
Cut In Material 83 83
Improper Flow or Infusion 78 78
Material Discolored 76 76
Image Display Error/Artifact 73 73
Migration or Expulsion of Device 73 73
Dull, Blunt 70 70
Incomplete or Inadequate Connection 68 68
Difficult to Remove 65 65
Device Fell 64 64
Failure to Interrogate 63 63
Unexpected Shutdown 59 59
Detachment Of Device Component 57 57
Nonstandard Device 55 55
Unintended Electrical Shock 55 55
Material Separation 49 49
Circuit Failure 44 44
Charging Problem 42 42
Moisture Damage 39 39
Power Conditioning Problem 39 39
Fitting Problem 35 35
Failure of Device to Self-Test 33 33

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19305 19305
No Known Impact Or Consequence To Patient 16802 16803
No Consequences Or Impact To Patient 13431 13431
Blood Loss 9971 9972
Unspecified Infection 8663 8663
Death 8387 8387
Thrombus 6591 6591
Hemolysis 6089 6090
Insufficient Information 4780 4780
Bacterial Infection 4156 4156
Stroke/CVA 3799 3799
Hemorrhage/Bleeding 3653 3653
Heart Failure/Congestive Heart Failure 3353 3353
Thrombosis/Thrombus 3096 3096
Sepsis 2526 2526
Arrhythmia 2424 2424
Renal Failure 2350 2350
Gastrointestinal Hemorrhage 2149 2149
Skin Infection 2113 2113
Respiratory Failure 1993 1993
Neurological Deficit/Dysfunction 1925 1925
Hemorrhage, Cerebral 1872 1872
Dyspnea 1500 1500
Anemia 1450 1450
Heart Failure 1353 1353
Multiple Organ Failure 1231 1231
Dizziness 1193 1193
Hematuria 1167 1168
Infarction, Cerebral 1154 1154
Post Operative Wound Infection 1076 1076
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1048 1048
Intracranial Hemorrhage 1026 1027
Tachycardia 956 956
Cardiac Arrest 878 878
Thrombosis 877 877
Hypervolemia 832 832
Fever 831 831
No Code Available 811 811
Fatigue 793 793
Right Ventricular Failure 789 789
Hemorrhagic Stroke 775 775
High Blood Pressure/ Hypertension 747 747
Unspecified Nervous System Problem 731 731
Thromboembolism 718 718
Low Blood Pressure/ Hypotension 708 708
Lactate Dehydrogenase Increased 680 680
Hematoma 660 660
Pain 599 599
Syncope/Fainting 587 587
Ischemia Stroke 586 586
Complaint, Ill-Defined 581 581
Cardiogenic Shock 567 567
Atrial Fibrillation 552 552
Weakness 534 534
Loss of consciousness 521 521
Syncope 494 494
Muscle Weakness 480 480
Pneumonia 470 470
Chest Pain 469 469
Fall 468 468
Ventricular Tachycardia 463 463
Transient Ischemic Attack 439 439
Ventricular Fibrillation 420 420
Nausea 389 389
Obstruction/Occlusion 389 389
Confusion/ Disorientation 387 387
Aortic Valve Insufficiency/ Regurgitation 387 387
Headache 385 385
Wound Dehiscence 376 376
Pleural Effusion 367 367
Purulent Discharge 340 340
Septic Shock 336 336
Renal Impairment 333 333
Ischemia 327 327
Vomiting 324 324
Melena 314 314
Cardiac Tamponade 308 308
Hypovolemia 301 301
Liver Damage/Dysfunction 298 298
No Information 292 292
Hemorrhage, Subarachnoid 289 289
Abdominal Pain 286 286
No Patient Involvement 280 280
Epistaxis 277 277
Encephalopathy 251 251
Swelling/ Edema 246 246
Hypoxia 243 243
Anxiety 242 242
Pericardial Effusion 236 236
Aortic Insufficiency 221 221
Fungal Infection 209 209
Fluid Discharge 206 206
Dehydration 198 198
Convulsion/Seizure 195 195
Drug Resistant Bacterial Infection 190 190
Seizures 172 172
Abscess 170 170
Dysphasia 168 168
Right Ventricular Dysfunction 167 167
Liver Failure 167 167

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 Abiomed, Inc. I Mar-04-2010
3 Abiomed, Inc. II Sep-16-2009
4 Abiomed, Inc. II Sep-01-2009
5 BERLIN HEART GMBH I May-25-2023
6 Datascope Corporation II Oct-24-2022
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 I Oct-13-2016
18 Heartware I May-21-2018
19 Heartware I Apr-27-2017
20 Heartware I Apr-25-2017
21 Heartware Inc II May-14-2013
22 Heartware, Inc. II Dec-02-2023
23 Heartware, Inc. II Jun-22-2023
24 Heartware, Inc. II Dec-21-2022
25 Heartware, Inc. I Aug-18-2022
26 Heartware, Inc. II May-17-2022
27 Heartware, Inc. II Mar-04-2022
28 Heartware, Inc. II Sep-16-2021
29 Heartware, Inc. I Aug-06-2021
30 Heartware, Inc. II Jul-13-2021
31 Heartware, Inc. II Apr-21-2021
32 Heartware, Inc. II Apr-20-2021
33 Heartware, Inc. I Apr-16-2021
34 Heartware, Inc. I Apr-06-2021
35 Heartware, Inc. I May-22-2020
36 Heartware, Inc. I Mar-09-2020
37 Heartware, Inc. II Dec-07-2018
38 Heartware, Inc. II Oct-03-2018
39 Heartware, Inc. I Oct-17-2016
40 Heartware, Inc. I Jul-08-2016
41 Jarvik Heart Inc II Dec-18-2018
42 Medtronic Inc I Jun-21-2022
43 Medtronic Inc I Jun-03-2022
44 Medtronic Inc II May-17-2022
45 Medtronic Inc I Feb-04-2021
46 Thoratec Corp II Nov-24-2009
47 Thoratec Corp II Oct-13-2010
48 Thoratec Corp. I Mar-22-2024
49 Thoratec Corp. I Feb-02-2024
50 Thoratec Corp. II Sep-29-2023
51 Thoratec Corp. II Nov-26-2021
52 Thoratec Corp. II Dec-27-2019
53 Thoratec Corp. II Aug-22-2019
54 Thoratec Corp. II Apr-19-2019
55 Thoratec Corporation I May-24-2017
56 Thoratec Corporation I Mar-21-2014
57 Thoratec Corporation I Mar-23-2012
-
-