Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ventricular (assist) bypass
Definition Approved pma: P870072
Product CodeDSQ
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
35 34 48 38 33 41

MDR Year MDR Reports MDR Events
2018 12660 12660
2019 20216 20216
2020 14238 14238
2021 15765 15765
2022 15994 15994
2023 11450 11450

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 50326 50326
Battery Problem 6010 6010
Pumping Problem 5858 5858
Mechanical Problem 5296 5296
Power Problem 4656 4656
Infusion or Flow Problem 3583 3583
Pumping Stopped 3233 3233
Break 2679 2679
Connection Problem 1797 1797
Material Integrity Problem 1703 1703
Electrical Power Problem 1575 1575
Complete Loss of Power 1538 1538
Disconnection 1503 1503
Electrical /Electronic Property Problem 1458 1458
Obstruction of Flow 1309 1309
Material Twisted/Bent 1255 1255
Insufficient Information 1120 1120
Material Split, Cut or Torn 994 994
Decreased Pump Speed 990 990
Material Deformation 701 701
No Apparent Adverse Event 600 600
Communication or Transmission Problem 542 542
Use of Device Problem 535 535
Display or Visual Feedback Problem 478 478
Device Difficult to Setup or Prepare 448 448
Noise, Audible 376 376
High Readings 355 355
Improper or Incorrect Procedure or Method 345 345
Device Stops Intermittently 345 345
Increase in Suction 294 294
Malposition of Device 289 289
Appropriate Term/Code Not Available 278 278
Device Displays Incorrect Message 257 257
Loss of Power 256 256
Overheating of Device 224 224
Device Alarm System 223 223
Naturally Worn 223 223
Output Problem 200 200
No Audible Alarm 197 197
Data Problem 173 173
Failure to Charge 162 162
Failure to Power Up 155 155
Failure to Pump 143 143
Fluid/Blood Leak 127 127
Failure to Align 119 119
Loose or Intermittent Connection 117 117
No Display/Image 114 114
Leak/Splash 101 101
Partial Blockage 97 97
Detachment of Device or Device Component 92 92
Deformation Due to Compressive Stress 90 90
Contamination /Decontamination Problem 87 87
Device Inoperable 86 86
Insufficient Flow or Under Infusion 84 84
Electro-Static Discharge 80 80
Contamination 75 75
Crack 72 72
Restricted Flow rate 70 70
Date/Time-Related Software Problem 69 69
Incomplete or Inadequate Connection 68 68
Electromagnetic Interference 68 68
Display Difficult to Read 68 68
Low Audible Alarm 68 68
Alarm Not Visible 63 63
Material Discolored 62 62
Device Fell 62 62
Corroded 61 61
Vibration 56 56
Low Readings 55 55
Difficult to Remove 55 55
Failure to Interrogate 53 53
Electrical Shorting 53 53
Unintended Electrical Shock 51 51
Unexpected Shutdown 51 51
Fracture 50 50
Device Contamination with Chemical or Other Material 41 41
Dull, Blunt 40 40
Premature Discharge of Battery 38 38
Kinked 35 35
Increased Pump Speed 35 35
Material Separation 34 34
Failure of Device to Self-Test 30 30
Protective Measures Problem 30 30
Device Operates Differently Than Expected 29 29
Therapeutic or Diagnostic Output Failure 28 28
Moisture Damage 28 28
Bent 27 27
Misconnection 27 27
Charging Problem 26 26
Premature Separation 24 24
Fitting Problem 24 24
Device Damaged Prior to Use 24 24
Component Missing 24 24
Nonstandard Device 24 24
Defective Device 22 22
Manufacturing, Packaging or Shipping Problem 22 22
Improper Flow or Infusion 21 21
Device Misassembled During Manufacturing /Shipping 21 21
Torn Material 21 21
Microbial Contamination of Device 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16972 16972
No Known Impact Or Consequence To Patient 11826 11827
Blood Loss 8054 8055
Unspecified Infection 7012 7012
Death 5095 5095
No Consequences Or Impact To Patient 5057 5057
Insufficient Information 4293 4293
Bacterial Infection 3734 3734
Hemolysis 3473 3473
Thrombus 3223 3223
Hemorrhage/Bleeding 3216 3216
Stroke/CVA 3161 3161
Heart Failure/Congestive Heart Failure 3030 3030
Thrombosis/Thrombus 2837 2837
Arrhythmia 2167 2167
Renal Failure 2038 2038
Gastrointestinal Hemorrhage 2028 2028
Sepsis 1960 1960
Skin Infection 1912 1912
Respiratory Failure 1739 1739
Dyspnea 1078 1078
Neurological Deficit/Dysfunction 1072 1072
Anemia 1069 1069
Hemorrhage, Cerebral 996 996
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 954 954
Heart Failure 871 871
Tachycardia 862 862
Intracranial Hemorrhage 859 860
Multiple Organ Failure 789 789
Dizziness 771 771
Thrombosis 760 760
Hypervolemia 751 751
Hemorrhagic Stroke 726 726
Hematuria 697 697
Unspecified Nervous System Problem 695 695
Cardiac Arrest 679 679
Fever 678 678
High Blood Pressure/ Hypertension 659 659
Thromboembolism 638 638
Lactate Dehydrogenase Increased 612 612
Infarction, Cerebral 596 596
Right Ventricular Failure 584 584
Fatigue 570 570
Low Blood Pressure/ Hypotension 559 559
Hematoma 552 552
Syncope/Fainting 544 544
Ischemia Stroke 521 521
Atrial Fibrillation 513 513
Cardiogenic Shock 444 444
Pain 433 433
Muscle Weakness 433 433
Weakness 425 425
Pneumonia 411 411
No Code Available 402 402
Fall 369 369
Ventricular Tachycardia 365 365
Post Operative Wound Infection 365 365
Loss of consciousness 364 364
Ventricular Fibrillation 360 360
Wound Dehiscence 354 354
Transient Ischemic Attack 353 353
Obstruction/Occlusion 351 351
Aortic Valve Insufficiency/ Regurgitation 348 348
Chest Pain 332 332
Confusion/ Disorientation 330 330
Pleural Effusion 328 328
Headache 311 311
Nausea 305 305
Renal Impairment 291 291
Septic Shock 285 285
Melena 283 283
Ischemia 278 278
Syncope 273 273
Epistaxis 266 266
Purulent Discharge 264 264
Vomiting 257 257
No Patient Involvement 247 247
Cardiac Tamponade 240 240
Hypovolemia 239 239
Liver Damage/Dysfunction 239 239
Abdominal Pain 234 234
Encephalopathy 232 232
Pericardial Effusion 207 207
Swelling/ Edema 206 206
Hypoxia 203 203
Dehydration 180 180
Convulsion/Seizure 180 180
Aortic Insufficiency 176 176
Fungal Infection 170 170
Fluid Discharge 164 164
Hemorrhage, Subarachnoid 162 162
Drug Resistant Bacterial Infection 161 161
Liver Failure 156 156
Right Ventricular Dysfunction 148 148
Dysphasia 145 145
Seizures 143 143
Pulmonary Edema 141 141
Paralysis 139 139
No Information 134 134
Urinary Tract Infection 132 132

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 BERLIN HEART GMBH I May-25-2023
3 Datascope Corporation II Oct-24-2022
4 Heartware I May-21-2018
5 Heartware, Inc. II Dec-02-2023
6 Heartware, Inc. II Jun-22-2023
7 Heartware, Inc. II Dec-21-2022
8 Heartware, Inc. I Aug-18-2022
9 Heartware, Inc. II May-17-2022
10 Heartware, Inc. II Mar-04-2022
11 Heartware, Inc. II Sep-16-2021
12 Heartware, Inc. I Aug-06-2021
13 Heartware, Inc. II Jul-13-2021
14 Heartware, Inc. II Apr-21-2021
15 Heartware, Inc. II Apr-20-2021
16 Heartware, Inc. I Apr-16-2021
17 Heartware, Inc. I Apr-06-2021
18 Heartware, Inc. I May-22-2020
19 Heartware, Inc. I Mar-09-2020
20 Heartware, Inc. II Dec-07-2018
21 Heartware, Inc. II Oct-03-2018
22 Jarvik Heart Inc II Dec-18-2018
23 Medtronic Inc I Jun-21-2022
24 Medtronic Inc I Jun-03-2022
25 Medtronic Inc II May-17-2022
26 Medtronic Inc I Feb-04-2021
27 Thoratec Corp. II Sep-29-2023
28 Thoratec Corp. II Nov-26-2021
29 Thoratec Corp. II Dec-27-2019
30 Thoratec Corp. II Aug-22-2019
31 Thoratec Corp. II Apr-19-2019
-
-