TPLC - Total Product Life Cycle

• Device: temporary non-roller type left heart support blood pump
• Definition: A blood pump that provides temporary full or partial left heart support
• Product Code: OZD
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
13	15	8	5	11	1

MDR Year	MDR Reports	MDR Events
2021	567	567
2022	542	542
2023	3849	3849
2024	18592	18592
2025	9875	9878
2026	3725	3725

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	17294	17294
Restricted Flow rate	2704	2706
Device Sensing Problem	2348	2348
Patient-Device Incompatibility	2007	2007
Pumping Stopped	1589	1590
Positioning Failure	1474	1474
Failure to Advance	1355	1355
Application Program Problem	1269	1269
Increase in Pressure	1162	1162
Malposition of Device	1110	1110
Fluid/Blood Leak	874	874
Patient Device Interaction Problem	835	835
Deformation Due to Compressive Stress	778	778
Battery Problem	627	627
Failure to Read Input Signal	600	600
Activation, Positioning or Separation Problem	600	600
Improper Flow or Infusion	492	492
Positioning Problem	467	467
Difficult to Advance	295	295
Difficult to Insert	293	293
Material Twisted/Bent	284	284
Infusion or Flow Problem	280	280
Material Split, Cut or Torn	262	262
No Pressure	236	236
Defective Device	230	230
Break	230	230
Computer Operating System Problem	199	199
Decrease in Pressure	198	198
Difficult to Remove	194	194
Priming Problem	184	184
Crack	176	176
Failure to Pump	167	167
Detachment of Device or Device Component	157	157
Connection Problem	146	146
Failure to Deliver	146	146
Fracture	139	139
Failure to Sense	131	131
False Alarm	127	127
Pressure Problem	123	123
Display or Visual Feedback Problem	119	119
Unintended Application Program Shut Down	106	106
Use of Device Problem	91	91
Inaccurate Flow Rate	90	90
Difficult or Delayed Positioning	87	87
Insufficient Flow or Under Infusion	69	69
Failure to Prime	66	66
Key or Button Unresponsive/not Working	61	61
Activation Failure	55	55
Material Deformation	45	45
Material Puncture/Hole	45	45

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14763	14764
Hemorrhage/Bleeding	8050	8051
Ischemia	3756	3756
Hemolysis	3218	3219
Hematoma	2383	2384
Thrombosis/Thrombus	2118	2118
Tachycardia	1425	1425
Arrhythmia	1084	1085
Stroke/CVA	942	942
Thrombocytopenia	760	760
Ventricular Fibrillation	678	678
Sepsis	578	578
Vascular Dissection	563	563
Renal Failure	528	528
Hematuria	474	474
Cardiovascular Insufficiency	472	472
Cardiac Arrest	462	462
Perforation of Vessels	399	399
Atrial Fibrillation	367	367
Unspecified Infection	349	349
Low Blood Pressure/ Hypotension	344	344
Cardiac Perforation	291	291
Insufficient Information	198	198
Ischemia Stroke	197	197
Fever	182	182
Unspecified Vascular Problem	153	153
Anemia	149	149
Gastrointestinal Hemorrhage	124	124
Pericardial Effusion	110	110
Hemorrhagic Stroke	106	106
Renal Impairment	89	89
Cardiac Tamponade	87	87
Bradycardia	87	87
Cardiogenic Shock	80	80
Pain	78	78
Aortic Valve Insufficiency/ Regurgitation	78	78
Respiratory Failure	77	77
Embolism/Embolus	71	71
Great Vessel Perforation	59	59
Multiple Organ Failure	58	58
Perforation	57	57
Ectopic Heartbeat	53	53
Heart Block	53	53
Pulmonary Edema	52	52
Mitral Valve Insufficiency/ Regurgitation	50	50
Heart Failure/Congestive Heart Failure	49	49
Asystole	48	48
Air Embolism	47	47
Hypovolemia	44	44
Inflammation	42	42

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