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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporary non-roller type left heart support blood pump
Definition A blood pump that provides temporary full or partial left heart support
Product CodeOZD
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
13 15 8 5 11 2

MDR Year MDR Reports MDR Events
2021 567 567
2022 542 542
2023 3849 3849
2024 18592 18592
2025 9878 9881
2026 7288 7288

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18308 18308
Restricted Flow rate 2940 2942
Device Sensing Problem 2773 2773
Patient-Device Incompatibility 2010 2010
Patient Device Interaction Problem 1723 1723
Pumping Stopped 1695 1696
Failure to Advance 1567 1567
Positioning Failure 1486 1486
Malposition of Device 1484 1484
Application Program Problem 1422 1422
Increase in Pressure 1372 1372
Fluid/Blood Leak 1002 1002
Deformation Due to Compressive Stress 912 912
Failure to Read Input Signal 730 730
Battery Problem 669 669
Activation, Positioning or Separation Problem 600 600
Improper Flow or Infusion 492 492
Positioning Problem 468 468
Difficult to Advance 336 336
Material Split, Cut or Torn 333 333
Difficult to Insert 325 325
Priming Problem 323 323
Material Twisted/Bent 288 288
Infusion or Flow Problem 280 280
Break 278 278
Decrease in Pressure 261 261
Computer Operating System Problem 240 240
No Pressure 236 236
Difficult to Remove 232 232
False Alarm 232 232
Defective Device 231 231
Crack 195 195
Failure to Pump 186 186
Detachment of Device or Device Component 160 160
Connection Problem 157 157
Failure to Deliver 146 146
Fracture 139 139
Display or Visual Feedback Problem 131 131
Failure to Sense 131 131
Pressure Problem 123 123
Inaccurate Flow Rate 122 122
Unintended Application Program Shut Down 121 121
Use of Device Problem 114 114
Difficult or Delayed Positioning 111 111
Electrical /Electronic Property Problem 75 75
Key or Button Unresponsive/not Working 74 74
Failure to Prime 69 69
Insufficient Flow or Under Infusion 69 69
Material Integrity Problem 67 67
No Apparent Adverse Event 58 58

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16164 16165
Hemorrhage/Bleeding 8726 8727
Ischemia 4014 4014
Hemolysis 3582 3583
Hematoma 2608 2609
Thrombosis/Thrombus 2245 2245
Tachycardia 1562 1562
Arrhythmia 1163 1164
Stroke/CVA 1064 1064
Thrombocytopenia 823 823
Ventricular Fibrillation 698 698
Hematuria 642 642
Renal Failure 627 627
Sepsis 601 601
Vascular Dissection 599 599
Cardiac Arrest 556 556
Cardiovascular Insufficiency 472 472
Low Blood Pressure/ Hypotension 431 431
Perforation of Vessels 418 418
Unspecified Infection 406 406
Atrial Fibrillation 386 386
Cardiac Perforation 329 329
Insufficient Information 202 202
Fever 199 199
Ischemia Stroke 197 197
Anemia 194 194
Unspecified Vascular Problem 153 153
Pericardial Effusion 130 130
Gastrointestinal Hemorrhage 124 124
Hemorrhagic Stroke 106 106
Cardiogenic Shock 103 103
Cardiac Tamponade 100 100
Pain 98 98
Bradycardia 94 94
Renal Impairment 92 92
Respiratory Failure 86 86
Aortic Valve Insufficiency/ Regurgitation 86 86
Thromboembolism 80 80
Embolism/Embolus 79 79
Multiple Organ Failure 71 71
Hypovolemia 67 67
Pulmonary Edema 63 63
Great Vessel Perforation 61 61
Heart Block 60 60
Heart Failure/Congestive Heart Failure 59 59
Mitral Valve Insufficiency/ Regurgitation 59 59
Perforation 57 57
Inflammation 56 56
Air Embolism 54 54
Ectopic Heartbeat 53 53

Recalls
Manufacturer Recall Class Date Posted
1 Abiomed, Inc. I May-28-2026
2 Abiomed, Inc. I May-22-2026
3 Abiomed, Inc. I Mar-31-2026
4 Abiomed, Inc. I Mar-27-2026
5 Abiomed, Inc. II Jan-08-2026
6 Abiomed, Inc. I Oct-17-2025
7 Abiomed, Inc. I Oct-09-2025
8 Abiomed, Inc. I Sep-19-2025
9 Abiomed, Inc. I Jul-26-2025
10 Abiomed, Inc. II Sep-04-2024
11 Abiomed, Inc. I Jul-17-2024
12 Abiomed, Inc. II Feb-22-2024
13 Abiomed, Inc. II Feb-12-2024
14 Abiomed, Inc. I Feb-09-2024
15 Abiomed, Inc. II Dec-01-2023
16 Abiomed, Inc. I Jul-14-2023
17 Abiomed, Inc. I May-18-2023
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