• 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 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 791 791

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3564 3564
Pumping Stopped 354 354
Fluid/Blood Leak 329 329
Activation, Positioning or Separation Problem 314 314
Improper Flow or Infusion 293 293
Restricted Flow rate 184 184
Positioning Problem 157 157
Material Twisted/Bent 142 142
Break 100 100
Increase in Pressure 79 79
Infusion or Flow Problem 70 70
Crack 66 66
Difficult to Advance 64 64
Insufficient Information 64 64
Device Sensing Problem 62 62
Application Program Problem 62 62
Fracture 61 61
Pressure Problem 60 60
Failure to Advance 58 58
Patient-Device Incompatibility 58 58
Battery Problem 54 54
Activation Failure 51 51
Computer Operating System Problem 49 49
Positioning Failure 48 48
Connection Problem 41 41
Detachment of Device or Device Component 37 37
Material Deformation 37 37
Failure to Deliver 32 32
Use of Device Problem 28 28
Deformation Due to Compressive Stress 27 27
Difficult to Remove 24 24
Material Split, Cut or Torn 24 24
Separation Problem 23 23
Migration 20 20
No Apparent Adverse Event 19 19
Device Handling Problem 19 19
Failure to Power Up 19 19
Insufficient Flow or Under Infusion 18 18
Optical Problem 17 17
Failure to Pump 17 17
Device Alarm System 17 17
Material Puncture/Hole 16 16
Leak/Splash 16 16
Activation Problem 16 16
Material Separation 15 15
Failure to Prime 13 13
Mechanical Problem 12 12
Material Integrity Problem 12 12
Malposition of Device 12 12
Unexpected Shutdown 12 12
Patient Device Interaction Problem 11 11
Display or Visual Feedback Problem 11 11
Communication or Transmission Problem 10 10
Protective Measures Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Unintended Movement 9 9
Priming Problem 9 9
Air/Gas in Device 8 8
Failure of Device to Self-Test 8 8
Material Frayed 8 8
Material Fragmentation 7 7
Device Dislodged or Dislocated 7 7
Physical Resistance/Sticking 7 7
Output Problem 6 6
Obstruction of Flow 6 6
Difficult to Insert 6 6
Failure to Run on Battery 6 6
No Display/Image 6 6
Defective Alarm 6 6
Contamination 5 5
Difficult or Delayed Positioning 5 5
Defective Component 5 5
Improper or Incorrect Procedure or Method 5 5
Suction Problem 5 5
Failure to Sense 5 5
Pumping Problem 5 5
Power Problem 4 4
Inaccurate Delivery 4 4
Failure to Read Input Signal 4 4
Failure to Analyze Signal 4 4
Unable to Obtain Readings 3 3
Device Difficult to Setup or Prepare 3 3
Migration or Expulsion of Device 3 3
Disconnection 3 3
Failure to Charge 3 3
Inadequate User Interface 3 3
Device Fell 3 3
Ejection Problem 3 3
Failure to Eject 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Noise, Audible 3 3
Failure to Shut Off 2 2
Device Contamination with Chemical or Other Material 2 2
Human-Device Interface Problem 2 2
Electrical Power Problem 2 2
Device Damaged by Another Device 2 2
Operating System Becomes Nonfunctional 2 2
Appropriate Term/Code Not Available 2 2
High Readings 2 2
Sensing Intermittently 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2417 2417
Hemorrhage/Bleeding 1016 1016
Ischemia 759 759
Hemolysis 677 677
Hematoma 413 413
Thrombosis/Thrombus 338 338
Vascular Dissection 167 167
Cardiac Perforation 124 124
Stroke/CVA 122 122
Blood Loss 118 118
Ischemia Stroke 110 110
Perforation of Vessels 87 87
Unspecified Infection 63 63
Tachycardia 52 52
Sepsis 50 50
Ventricular Fibrillation 43 43
No Known Impact Or Consequence To Patient 42 42
Renal Failure 41 41
Hemostasis 37 37
Thrombocytopenia 37 37
Insufficient Information 36 36
Aortic Valve Insufficiency/ Regurgitation 30 30
Perforation 26 26
Cardiac Arrest 21 21
Hematuria 21 21
Cardiac Tamponade 21 21
Thrombus 20 20
Death 17 17
Renal Impairment 16 16
Air Embolism 15 15
Mitral Regurgitation 15 15
Device Embedded In Tissue or Plaque 15 15
Low Blood Pressure/ Hypotension 14 14
Arrhythmia 14 14
Aortic Regurgitation 12 12
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
Rupture 9 9
Hemorrhagic Stroke 8 8
No Code Available 8 8
Mitral Perforation 7 7
Unspecified Vascular Problem 7 7
Bacterial Infection 7 7
No Consequences Or Impact To Patient 6 6
Pseudoaneurysm 6 6
Swelling/ Edema 6 6
Aortic Dissection 5 5
Low Cardiac Output 5 5
Cardiogenic Shock 5 5
Pericardial Effusion 5 5
Anemia 5 5
Aneurysm 5 5
Infarction, Cerebral 5 5
Failure of Implant 5 5
Insufficiency, Valvular 5 5
Mitral Insufficiency 5 5
Pain 5 5
Thrombosis 4 4
Hemorrhage, Cerebral 4 4
Aortic Insufficiency 4 4
Foreign Body In Patient 4 4
Patient Problem/Medical Problem 4 4
Unspecified Heart Problem 4 4
Embolism/Embolus 4 4
Injury 4 4
Transient Ischemic Attack 3 3
Great Vessel Perforation 3 3
Ectopic Heartbeat 3 3
Heart Block 3 3
Gastrointestinal Hemorrhage 3 3
Not Applicable 3 3
No Information 3 3
Atrial Fibrillation 3 3
Bradycardia 3 3
Coagulation Disorder 3 3
Myocardial Infarction 3 3
Nausea 3 3
Necrosis 2 2
Nerve Damage 2 2
Inflammation 2 2
Hypoxia 2 2
Ventricle, Abnormality Of 2 2
Septic Shock 2 2
Paralysis 2 2
Chest Pain 2 2
Hemothorax 2 2
Pulmonary Embolism 2 2
Multiple Organ Failure 2 2
Vomiting 2 2
Hemolytic Anemia 2 2
Anxiety 2 2
Ulcer 1 1
Hernia 1 1
Loss of Vision 1 1
Tissue Damage 1 1
Depression 1 1
Ventilator Dependent 1 1
Numbness 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
-
-