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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventricular (assist) bypass
Definition Approved pma: P870072
Product CodeDSQ
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
34 48 38 33 48 8

MDR Year MDR Reports MDR Events
2019 20216 20216
2020 14238 14238
2021 15765 15765
2022 15994 15994
2023 13056 13056
2024 934 934

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 46204 46204
Mechanical Problem 5576 5576
Pumping Problem 5291 5291
Battery Problem 4836 4836
Power Problem 3459 3459
Infusion or Flow Problem 3259 3259
Pumping Stopped 2809 2809
Break 1662 1662
Electrical Power Problem 1654 1654
Complete Loss of Power 1616 1616
Electrical /Electronic Property Problem 1461 1461
Disconnection 1440 1440
Material Integrity Problem 1384 1384
Material Twisted/Bent 1180 1180
Insufficient Information 1140 1140
Connection Problem 1034 1034
Decreased Pump Speed 929 929
Material Split, Cut or Torn 898 898
Obstruction of Flow 893 893
No Apparent Adverse Event 670 670
Communication or Transmission Problem 561 561
Device Difficult to Setup or Prepare 488 488
Material Deformation 483 483
Use of Device Problem 448 448
Display or Visual Feedback Problem 445 445
Improper or Incorrect Procedure or Method 374 374
Noise, Audible 356 356
Increase in Suction 253 253
Malposition of Device 237 237
Overheating of Device 225 225
Appropriate Term/Code Not Available 205 205
Loss of Power 197 197
No Audible Alarm 174 174
Naturally Worn 171 171
Failure to Pump 169 169
Failure to Charge 168 168
Device Alarm System 161 161
Data Problem 158 158
Failure to Power Up 152 152
Output Problem 142 142
Fluid/Blood Leak 135 135
Failure to Align 128 128
High Readings 106 106
No Display/Image 100 100
Contamination /Decontamination Problem 94 94
Deformation Due to Compressive Stress 87 87
Electro-Static Discharge 81 81
Display Difficult to Read 80 80
Detachment of Device or Device Component 80 80
Corroded 74 74
Loose or Intermittent Connection 74 74
Electromagnetic Interference 73 73
Leak/Splash 67 67
Alarm Not Visible 66 66
Insufficient Flow or Under Infusion 65 65
Low Audible Alarm 64 64
Material Discolored 63 63
Incomplete or Inadequate Connection 63 63
Device Fell 60 60
Dull, Blunt 59 59
Contamination 58 58
Failure to Interrogate 57 57
Date/Time-Related Software Problem 56 56
Unexpected Shutdown 53 53
Difficult to Remove 52 52
Unintended Electrical Shock 50 50
Fracture 48 48
Crack 45 45
Premature Discharge of Battery 42 42
Vibration 42 42
Device Displays Incorrect Message 38 38
Low Readings 38 38
Increased Pump Speed 33 33
Failure of Device to Self-Test 33 33
Therapeutic or Diagnostic Output Failure 28 28
Material Separation 27 27
Misconnection 26 26
Moisture Damage 26 26
Premature Separation 26 26
Device Contamination with Chemical or Other Material 25 25
Protective Measures Problem 24 24
Off-Label Use 22 22
Manufacturing, Packaging or Shipping Problem 21 21
Electrical Shorting 20 20
Gas/Air Leak 19 19
Material Too Rigid or Stiff 19 19
Component Missing 19 19
Microbial Contamination of Device 18 18
Tear, Rip or Hole in Device Packaging 18 18
Fitting Problem 18 18
Nonstandard Device 18 18
Improper Flow or Infusion 17 17
Environmental Compatibility Problem 17 17
Material Protrusion/Extrusion 17 17
Patient Device Interaction Problem 15 15
Sparking 15 15
Defective Device 13 13
Separation Failure 12 12
Material Puncture/Hole 12 12
Particulates 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18298 18298
No Known Impact Or Consequence To Patient 6708 6708
Blood Loss 6483 6483
Unspecified Infection 5620 5620
No Consequences Or Impact To Patient 4558 4558
Insufficient Information 4547 4547
Bacterial Infection 3814 3814
Death 3783 3783
Hemorrhage/Bleeding 3273 3273
Heart Failure/Congestive Heart Failure 3193 3193
Thrombosis/Thrombus 2942 2942
Stroke/CVA 2702 2702
Hemolysis 2697 2697
Arrhythmia 2132 2132
Gastrointestinal Hemorrhage 2083 2083
Skin Infection 2058 2058
Thrombus 2045 2045
Renal Failure 1917 1917
Sepsis 1801 1801
Respiratory Failure 1673 1673
Dyspnea 1010 1010
Anemia 1002 1002
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 977 977
Tachycardia 901 901
Intracranial Hemorrhage 843 843
Hemorrhagic Stroke 758 758
Hypervolemia 748 748
Multiple Organ Failure 714 714
Unspecified Nervous System Problem 703 703
Neurological Deficit/Dysfunction 691 691
Hemorrhage, Cerebral 687 687
Dizziness 679 679
Cardiac Arrest 657 657
High Blood Pressure/ Hypertension 653 653
Heart Failure 653 653
Lactate Dehydrogenase Increased 653 653
Fever 630 630
Thromboembolism 579 579
Hematuria 572 572
Syncope/Fainting 565 565
Ischemia Stroke 564 564
Low Blood Pressure/ Hypotension 561 561
Thrombosis 553 553
Hematoma 544 544
Atrial Fibrillation 508 508
Fatigue 502 502
Infarction, Cerebral 457 457
Muscle Weakness 454 454
Right Ventricular Failure 448 448
Cardiogenic Shock 427 427
Pneumonia 419 419
Pain 387 387
Aortic Valve Insufficiency/ Regurgitation 373 373
Loss of consciousness 355 355
Ventricular Fibrillation 355 355
Fall 352 352
Obstruction/Occlusion 351 351
No Code Available 338 338
Transient Ischemic Attack 325 325
Weakness 325 325
Renal Impairment 317 317
Confusion/ Disorientation 316 316
Pleural Effusion 309 309
Melena 308 308
Chest Pain 303 303
Headache 299 299
Ventricular Tachycardia 293 293
Wound Dehiscence 291 291
Nausea 288 288
Septic Shock 284 284
Epistaxis 274 274
Purulent Discharge 265 265
Ischemia 258 258
Vomiting 245 245
Hypovolemia 245 245
Encephalopathy 230 230
Abdominal Pain 229 229
Swelling/ Edema 225 225
Post Operative Wound Infection 219 219
Liver Damage/Dysfunction 213 213
Cardiac Tamponade 211 211
Hypoxia 197 197
No Patient Involvement 191 191
Syncope 190 190
Pericardial Effusion 189 189
Fluid Discharge 185 185
Convulsion/Seizure 183 183
Fungal Infection 180 180
Drug Resistant Bacterial Infection 180 180
Dehydration 179 179
Liver Failure 162 162
Dysphasia 145 145
Paralysis 142 142
Urinary Tract Infection 134 134
Pulmonary Edema 132 132
Viral Infection 130 130
Seizures 124 124
Abscess 123 123
No Information 123 123
Right Ventricular Dysfunction 122 122

Recalls
Manufacturer Recall Class Date Posted
1 BERLIN HEART GMBH I May-25-2023
2 Datascope Corporation II Oct-24-2022
3 Heartware, Inc. II Dec-02-2023
4 Heartware, Inc. II Jun-22-2023
5 Heartware, Inc. II Dec-21-2022
6 Heartware, Inc. I Aug-18-2022
7 Heartware, Inc. II May-17-2022
8 Heartware, Inc. II Mar-04-2022
9 Heartware, Inc. II Sep-16-2021
10 Heartware, Inc. I Aug-06-2021
11 Heartware, Inc. II Jul-13-2021
12 Heartware, Inc. II Apr-21-2021
13 Heartware, Inc. II Apr-20-2021
14 Heartware, Inc. I Apr-16-2021
15 Heartware, Inc. I Apr-06-2021
16 Heartware, Inc. I May-22-2020
17 Heartware, Inc. I Mar-09-2020
18 Medtronic Inc I Jun-21-2022
19 Medtronic Inc I Jun-03-2022
20 Medtronic Inc II May-17-2022
21 Medtronic Inc I Feb-04-2021
22 Thoratec Corp. I Feb-02-2024
23 Thoratec Corp. II Sep-29-2023
24 Thoratec Corp. II Nov-26-2021
25 Thoratec Corp. II Dec-27-2019
26 Thoratec Corp. II Aug-22-2019
27 Thoratec Corp. II Apr-19-2019
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