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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)
2017 2018 2019 2020 2021 2022
36 35 34 48 38 22

MDR Year MDR Reports MDR Events
2017 9055 9055
2018 12660 12660
2019 20216 20216
2020 14238 14238
2021 15766 15766
2022 8305 8305

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 41497 41497
Battery Problem 5764 5764
Pumping Problem 5376 5376
Power Problem 4974 4974
Mechanical Problem 3534 3534
Break 3152 3152
Infusion or Flow Problem 3049 3049
Pumping Stopped 2728 2728
Connection Problem 2127 2127
Material Integrity Problem 1932 1932
Obstruction of Flow 1433 1433
Material Twisted/Bent 1076 1076
Electrical /Electronic Property Problem 1076 1076
Disconnection 1064 1064
Complete Loss of Power 1030 1030
Electrical Power Problem 1019 1019
Device Stops Intermittently 942 942
Decreased Pump Speed 917 917
Material Split, Cut or Torn 883 883
Insufficient Information 789 789
High Readings 745 745
Material Deformation 696 696
Loose or Intermittent Connection 658 658
Use of Device Problem 428 428
Device Displays Incorrect Message 420 420
Communication or Transmission Problem 363 363
No Apparent Adverse Event 307 307
Display or Visual Feedback Problem 305 305
Malposition of Device 294 294
Noise, Audible 272 272
Appropriate Term/Code Not Available 258 258
Loss of Power 257 257
Device Difficult to Setup or Prepare 250 250
Increase in Suction 242 242
Naturally Worn 232 232
Device Alarm System 219 219
Output Problem 209 209
Partial Blockage 200 200
No Audible Alarm 191 191
Protective Measures Problem 183 183
Restricted Flow rate 180 180
Overheating of Device 176 176
Data Problem 154 154
Improper or Incorrect Procedure or Method 136 136
Electrical Shorting 131 131
Date/Time-Related Software Problem 128 128
No Display/Image 123 123
Device Inoperable 116 116
Crack 112 112
Failure to Charge 110 110
Leak/Splash 109 109
Failure to Power Up 97 97
Failure to Pump 97 97
Insufficient Flow or Under Infusion 87 87
Fluid Leak 85 85
Contamination 72 72
Device Operates Differently Than Expected 70 70
Deformation Due to Compressive Stress 67 67
Kinked 67 67
Detachment of Device or Device Component 66 66
Low Readings 65 65
Incomplete or Inadequate Connection 64 64
Failure to Align 63 63
Device Fell 57 57
Fracture 56 56
Electro-Static Discharge 56 56
Low Audible Alarm 55 55
Torn Material 53 53
Vibration 48 48
Contamination /Decontamination Problem 47 47
Alarm Not Visible 43 43
Material Discolored 42 42
Electromagnetic Interference 42 42
Occlusion Within Device 42 42
Difficult to Remove 41 41
Material Separation 41 41
Bent 41 41
Device Contamination with Chemical or Other Material 41 41
Unintended Electrical Shock 36 36
Corroded 32 32
Migration or Expulsion of Device 32 32
Cut In Material 30 30
Fitting Problem 28 28
Device Damaged Prior to Use 27 27
Moisture Damage 27 27
Premature Discharge of Battery 27 27
Microbial Contamination of Device 26 26
Therapeutic or Diagnostic Output Failure 26 26
Component Missing 25 25
Charging Problem 24 24
Improper Flow or Infusion 23 23
Unexpected Shutdown 23 23
Material Protrusion/Extrusion 23 23
Maintenance Does Not Comply To Manufacturers Recommendations 23 23
Display Difficult to Read 23 23
Misconnection 22 22
Misassembled 21 21
Device Misassembled During Manufacturing /Shipping 21 21
Tear, Rip or Hole in Device Packaging 19 19
Manufacturing, Packaging or Shipping Problem 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13818 13819
No Clinical Signs, Symptoms or Conditions 10397 10397
Blood Loss 8872 8873
No Consequences Or Impact To Patient 7394 7394
Unspecified Infection 6621 6621
Death 5966 5966
Thrombus 4353 4353
Hemolysis 3978 3979
Stroke/CVA 2778 2778
Bacterial Infection 2411 2411
Hemorrhage/Bleeding 2195 2195
Thrombosis/Thrombus 1806 1806
Sepsis 1742 1742
Arrhythmia 1709 1709
Heart Failure/Congestive Heart Failure 1683 1683
Renal Failure 1645 1645
Respiratory Failure 1494 1494
Insufficient Information 1440 1440
Neurological Deficit/Dysfunction 1436 1436
Hemorrhage, Cerebral 1310 1310
Gastrointestinal Hemorrhage 1237 1237
Heart Failure 1025 1025
Anemia 1002 1002
Skin Infection 902 902
Dyspnea 811 811
Infarction, Cerebral 794 794
Thrombosis 788 788
Multiple Organ Failure 732 732
Hematuria 701 702
Post Operative Wound Infection 699 699
Dizziness 656 656
Right Ventricular Failure 652 652
Intracranial Hemorrhage 614 615
Thromboembolism 551 551
Fever 543 543
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 542 542
Tachycardia 515 515
Fatigue 501 501
High Blood Pressure/ Hypertension 486 486
Weakness 480 480
Cardiac Arrest 469 469
No Code Available 437 437
Unspecified Nervous System Problem 437 437
Atrial Fibrillation 426 426
Hematoma 425 425
Hemorrhagic Stroke 412 412
Low Blood Pressure/ Hypotension 411 411
Ventricular Tachycardia 409 409
Pain 386 386
Hypervolemia 374 374
Cardiogenic Shock 356 356
Lactate Dehydrogenase Increased 353 353
Syncope 350 350
Wound Dehiscence 333 333
Syncope/Fainting 307 307
Muscle Weakness 306 306
Transient Ischemic Attack 300 300
Confusion/ Disorientation 288 288
Obstruction/Occlusion 276 276
Loss of consciousness 269 269
Headache 266 266
Fall 265 265
Pleural Effusion 265 265
No Patient Involvement 262 262
Ischemia Stroke 255 255
Chest Pain 241 241
Ventricular Fibrillation 234 234
Complaint, Ill-Defined 232 232
Pneumonia 227 227
Nausea 226 226
Cardiac Tamponade 224 224
Ischemia 218 218
Hemorrhage, Subarachnoid 215 215
Liver Damage/Dysfunction 204 204
Encephalopathy 202 202
Aortic Insufficiency 196 196
Vomiting 196 196
Septic Shock 196 196
Pericardial Effusion 193 193
Purulent Discharge 177 177
Melena 168 168
Abdominal Pain 167 167
Aortic Valve Insufficiency/ Regurgitation 163 163
Seizures 158 158
Right Ventricular Dysfunction 156 156
Hypovolemia 150 150
No Information 148 148
Hypoxia 146 146
Anxiety 145 145
Epistaxis 141 141
Renal Impairment 135 135
Dysphasia 130 130
Coma 115 115
Abscess 112 112
Edema 112 112
Dehydration 110 110
Convulsion/Seizure 109 109
Paralysis 108 108
Hemorrhage, Subdural 107 107
Respiratory Distress 104 104

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 Heartware I May-21-2018
3 Heartware I Apr-27-2017
4 Heartware I Apr-25-2017
5 Heartware, Inc. II May-17-2022
6 Heartware, Inc. II Mar-04-2022
7 Heartware, Inc. II Sep-16-2021
8 Heartware, Inc. I Aug-06-2021
9 Heartware, Inc. II Jul-13-2021
10 Heartware, Inc. II Apr-21-2021
11 Heartware, Inc. II Apr-20-2021
12 Heartware, Inc. I Apr-16-2021
13 Heartware, Inc. I Apr-06-2021
14 Heartware, Inc. I May-22-2020
15 Heartware, Inc. I Mar-09-2020
16 Heartware, Inc. II Dec-07-2018
17 Heartware, Inc. II Oct-03-2018
18 Jarvik Heart Inc II Dec-18-2018
19 Medtronic Inc I Jun-21-2022
20 Medtronic Inc I Jun-03-2022
21 Medtronic Inc II May-17-2022
22 Medtronic Inc I Feb-04-2021
23 Thoratec Corp. II Nov-26-2021
24 Thoratec Corp. II Dec-27-2019
25 Thoratec Corp. II Aug-22-2019
26 Thoratec Corp. II Apr-19-2019
27 Thoratec Corporation I May-24-2017
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