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)
2021 2022 2023 2024 2025 2026
38 33 48 61 50 37

MDR Year MDR Reports MDR Events
2021 15766 15769
2022 15994 16002
2023 13055 13058
2024 13046 13048
2025 10580 10581
2026 6231 6231

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 40135 40138
Mechanical Problem 7351 7351
Infusion or Flow Problem 4961 4961
Pumping Problem 4704 4704
Battery Problem 3950 3950
Electrical Power Problem 2892 2892
Pumping Stopped 2408 2408
Disconnection 2330 2330
Complete Loss of Power 2318 2318
Electrical /Electronic Property Problem 2160 2160
Insufficient Device Problem Information 1876 1877
No Apparent Adverse Event 1727 1727
Power Problem 1475 1475
Material Integrity Problem 1459 1459
Use of Device Problem 989 989
Display or Visual Feedback Problem 960 960
Communication or Transmission Problem 946 946
Device Difficult to Setup or Prepare 832 832
Material Deformation 764 764
Decreased Pump Speed 748 748
Material Twisted/Bent 722 722
Improper or Incorrect Procedure or Method 709 709
Break 610 610
Failure to Charge 593 593
Noise, Audible 441 441
Obstruction of Flow 436 436
Connection Problem 426 426
Material Split, Cut or Torn 390 390
Overheating of Device 309 309
Corroded 264 264
Display Difficult to Read 238 238
Increase in Suction 228 228
Failure to Pump 224 224
Failure to Power Up 211 211
Fluid/Blood Leak 210 210
Failure to Align 207 207
No Audible Alarm 201 201
Malposition of Device 188 188
Contamination /Decontamination Problem 187 187
Electromagnetic Interference 186 186
Data Problem 172 172
Electrostatic Discharge 132 132
No Display/Image 130 130
Unintended Electrical Shock 124 124
Failure to Interrogate 124 124
Dull, Blunt 106 106
Low Audible Alarm 104 104
Material Discolored 103 103
Alarm Not Visible 102 102
Deformation Due to Compressive Stress 91 91

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30681 30689
Insufficient Information 7310 7312
Heart Failure/Congestive Heart Failure 4930 4930
Hemorrhage/Blood Loss/Bleeding 4005 4006
Bacterial Infection 3914 3915
Thrombosis/Thrombus 3909 3909
Unspecified Infection 3279 3279
Skin Infection 2949 2949
Gastrointestinal Hemorrhage 2832 2832
Arrhythmia 2517 2517
Renal Failure 1857 1857
Stroke/CVA 1840 1840
Hemolysis 1809 1809
Respiratory Failure 1422 1425
Tachycardia 1383 1383
Sepsis 1340 1340
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1335 1335
High Blood Pressure/ Hypertension 1295 1295
Dyspnea 1222 1222
Intracranial Hemorrhage 1102 1102
Hypervolemia 1095 1095
Hemorrhagic Stroke 995 995
Multiple Organ Dysfunction Syndrome 975 976
Unspecified Nervous System Problem 934 934
Cardiac Arrest 903 903
Ischemia Stroke 902 902
Lactate Dehydrogenase Increased 880 880
Syncope/Fainting 860 860
Dizziness 816 816
Hemodynamic instability 735 736
Anemia 724 724
Aortic Valve Insufficiency/ Regurgitation 709 709
Low Blood Pressure/ Hypotension 689 689
Fever 657 659
Muscle Weakness/Atrophy 608 608
Ventricular Fibrillation 604 604
Pneumonia 578 578
Fatigue 558 558
Atrial Fibrillation 534 534
Renal Impairment 514 514
Cardiogenic Shock 514 514
Hematoma 513 513
Loss of consciousness 448 448
Fall 424 424
Chest Pain 417 417
Pain 403 403
Obstruction/Occlusion 398 398
Melena 391 391
Hematuria 387 387
Septic Shock 387 387

Recalls
Manufacturer Recall Class Date Posted
1 BERLIN HEART GMBH II Jun-05-2026
2 BERLIN HEART GMBH I May-25-2023
3 Datascope Corporation II Oct-24-2022
4 Heartware, Inc. II Dec-02-2023
5 Heartware, Inc. II Jun-22-2023
6 Heartware, Inc. II Dec-21-2022
7 Heartware, Inc. I Aug-18-2022
8 Heartware, Inc. II May-17-2022
9 Heartware, Inc. II Mar-04-2022
10 Heartware, Inc. II Sep-16-2021
11 Heartware, Inc. I Aug-06-2021
12 Heartware, Inc. II Jul-13-2021
13 Heartware, Inc. II Apr-21-2021
14 Heartware, Inc. II Apr-20-2021
15 Heartware, Inc. I Apr-16-2021
16 Heartware, Inc. I Apr-06-2021
17 Heartware, Inc. I Feb-04-2021
18 Medtronic Inc I Jun-21-2022
19 Medtronic Inc I Jun-03-2022
20 Medtronic Inc II May-17-2022
21 Thoratec Corp. I Jun-07-2024
22 Thoratec Corp. I May-01-2024
23 Thoratec Corp. I Mar-22-2024
24 Thoratec Corp. I Feb-02-2024
25 Thoratec Corp. II Sep-29-2023
26 Thoratec Corp. II Nov-26-2021
27 Thoratec LLC II Jun-18-2026
28 Thoratec LLC II Nov-14-2025
29 Thoratec LLC I Aug-13-2025
30 Thoratec LLC I Apr-17-2025
31 Thoratec LLC II Aug-13-2024
32 Thoratec Switzerland GMBH II Jun-27-2024
-
-