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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)
2019 2020 2021 2022 2023 2024
19 12 13 15 8 1

MDR Year MDR Reports MDR Events
2019 300 300
2020 341 341
2021 567 567
2022 542 542
2023 3852 3852
2024 3301 3301

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4920 4920
Activation, Positioning or Separation Problem 482 482
Pumping Stopped 436 436
Improper Flow or Infusion 397 397
Fluid/Blood Leak 363 363
Positioning Problem 266 266
Patient-Device Incompatibility 254 254
Restricted Flow rate 233 233
Material Twisted/Bent 176 176
Difficult to Advance 152 152
Break 134 134
Computer Operating System Problem 109 109
Failure to Advance 107 107
Increase in Pressure 105 105
Difficult to Insert 104 104
Pressure Problem 97 97
Device Sensing Problem 90 90
Infusion or Flow Problem 86 86
Application Program Problem 80 80
Battery Problem 78 78
Positioning Failure 76 76
Crack 73 73
Failure to Deliver 73 73
Connection Problem 69 69
Fracture 67 67
Insufficient Information 64 64
Activation Failure 52 52
Insufficient Flow or Under Infusion 48 48
Detachment of Device or Device Component 42 42
Material Deformation 40 40
Deformation Due to Compressive Stress 39 39
Material Split, Cut or Torn 38 38
Difficult to Remove 33 33
Use of Device Problem 30 30
Separation Problem 27 27
Optical Problem 26 26
Device Handling Problem 25 25
Material Separation 24 24
Activation Problem 22 22
Malposition of Device 21 21
Failure to Pump 20 20
Device Alarm System 20 20
No Apparent Adverse Event 20 20
Migration 20 20
Material Puncture/Hole 19 19
Failure to Power Up 19 19
Leak/Splash 19 19
Material Integrity Problem 18 18
Failure to Prime 15 15
Display or Visual Feedback Problem 15 15
Patient Device Interaction Problem 15 15
Unexpected Shutdown 15 15
Unintended Movement 14 14
Mechanical Problem 13 13
Failure of Device to Self-Test 12 12
Pumping Problem 12 12
Power Problem 11 11
Priming Problem 11 11
Device Dislodged or Dislocated 11 11
Suction Problem 11 11
Inaccurate Delivery 10 10
Communication or Transmission Problem 10 10
Protective Measures Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Air/Gas in Device 9 9
Defective Component 9 9
Material Frayed 8 8
Difficult or Delayed Positioning 8 8
Defective Alarm 8 8
Material Fragmentation 7 7
Physical Resistance/Sticking 7 7
Output Problem 6 6
Failure to Run on Battery 6 6
No Display/Image 6 6
Obstruction of Flow 6 6
Improper or Incorrect Procedure or Method 6 6
Failure to Sense 5 5
Failure to Read Input Signal 5 5
Contamination 5 5
Failure to Charge 5 5
Component Incompatible 4 4
Inaccurate Flow Rate 4 4
Device Difficult to Setup or Prepare 4 4
Failure to Analyze Signal 4 4
Migration or Expulsion of Device 4 4
Device Fell 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Ejection Problem 3 3
Failure to Eject 3 3
Noise, Audible 3 3
Unable to Obtain Readings 3 3
Decrease in Pressure 3 3
Disconnection 3 3
Erratic or Intermittent Display 3 3
Unraveled Material 3 3
Difficult or Delayed Activation 3 3
Charging Problem 3 3
Failure to Shut Off 3 3
Inadequate User Interface 3 3
Device Contamination with Chemical or Other Material 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3416 3416
Hemorrhage/Bleeding 1667 1667
Ischemia 1093 1093
Hemolysis 860 860
Hematoma 616 616
Thrombosis/Thrombus 486 486
Vascular Dissection 209 209
Stroke/CVA 160 160
Cardiac Perforation 138 138
Ischemia Stroke 124 124
Tachycardia 120 120
Blood Loss 118 118
Perforation of Vessels 114 114
Ventricular Fibrillation 91 91
Thrombocytopenia 71 71
Unspecified Infection 67 67
Sepsis 65 65
Arrhythmia 52 52
Renal Failure 48 48
No Known Impact Or Consequence To Patient 42 42
Hemostasis 37 37
Insufficient Information 36 36
Hematuria 32 32
Aortic Valve Insufficiency/ Regurgitation 31 31
Perforation 30 30
Cardiac Arrest 24 24
Cardiac Tamponade 21 21
Thrombus 20 20
Renal Impairment 20 20
Hemorrhagic Stroke 17 17
Air Embolism 17 17
Death 17 17
Mitral Regurgitation 15 15
Device Embedded In Tissue or Plaque 15 15
Low Blood Pressure/ Hypotension 14 14
Atrial Fibrillation 14 14
Aortic Regurgitation 12 12
Unspecified Vascular Problem 11 11
Mitral Valve Insufficiency/ Regurgitation 11 11
Valvular Insufficiency/ Regurgitation 11 11
Retroperitoneal Hemorrhage 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Gastrointestinal Hemorrhage 9 9
Rupture 9 9
Anemia 9 9
Mitral Perforation 8 8
Pseudoaneurysm 8 8
No Code Available 8 8
Pericardial Effusion 8 8
Embolism/Embolus 7 7
Bacterial Infection 7 7
Pain 7 7
Aneurysm 6 6
No Consequences Or Impact To Patient 6 6
Swelling/ Edema 6 6
Cardiogenic Shock 5 5
Aortic Dissection 5 5
Low Cardiac Output 5 5
Heart Block 5 5
Bradycardia 5 5
Infarction, Cerebral 5 5
Mitral Insufficiency 5 5
Failure of Implant 5 5
Insufficiency, Valvular 5 5
Hemorrhage, Cerebral 4 4
Aortic Insufficiency 4 4
Unspecified Heart Problem 4 4
Foreign Body In Patient 4 4
Patient Problem/Medical Problem 4 4
Injury 4 4
Great Vessel Perforation 4 4
Thrombosis 4 4
Transient Ischemic Attack 3 3
Diminished Pulse Pressure 3 3
Not Applicable 3 3
No Information 3 3
Ectopic Heartbeat 3 3
Coagulation Disorder 3 3
Myocardial Infarction 3 3
Nausea 3 3
Nerve Damage 3 3
Septic Shock 3 3
Ventricle, Abnormality Of 2 2
Paralysis 2 2
Pulmonary Edema 2 2
Necrosis 2 2
Inflammation 2 2
Hypoxia 2 2
Hemothorax 2 2
Chest Pain 2 2
Pulmonary Embolism 2 2
Abdominal Pain 2 2
Heart Failure/Congestive Heart Failure 2 2
Multiple Organ Failure 2 2
Vomiting 2 2
Obstruction/Occlusion 2 2
Hemolytic Anemia 2 2
Anxiety 2 2
Atrial Perforation 1 1
Underdose 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abiomed, Inc. II Feb-22-2024
2 Abiomed, Inc. II Feb-12-2024
3 Abiomed, Inc. I Feb-09-2024
4 Abiomed, Inc. II Dec-01-2023
5 Abiomed, Inc. I Jul-14-2023
6 Abiomed, Inc. I May-18-2023
7 Abiomed, Inc. II Nov-07-2019
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