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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, hemostasis, vascular
Product CodeMGB
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
27 10 17 11 18 14

MDR Year MDR Reports MDR Events
2019 6156 6156
2020 5927 5927
2021 7586 7586
2022 9457 9466
2023 13529 13529
2024 9210 9210

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 26123 26123
Material Separation 5866 5866
Malposition of Device 2388 2388
Improper or Incorrect Procedure or Method 2247 2247
Adverse Event Without Identified Device or Use Problem 1570 1570
Insufficient Information 1495 1495
Off-Label Use 1448 1448
Patient Device Interaction Problem 1445 1445
Activation, Positioning or Separation Problem 1434 1434
Entrapment of Device 1310 1310
Difficult to Open or Close 1274 1274
Difficult to Remove 1173 1173
Obstruction of Flow 1084 1084
Difficult to Insert 866 866
Physical Resistance/Sticking 733 733
Activation Failure 712 712
Decrease in Pressure 697 697
Mechanical Jam 673 673
Material Deformation 618 618
Detachment of Device or Device Component 613 613
Break 600 600
Material Rupture 595 595
Failure to Advance 576 576
Failure to Fire 571 571
Difficult to Advance 444 444
Product Quality Problem 439 439
Premature Activation 409 409
Retraction Problem 348 348
Positioning Failure 327 327
Deformation Due to Compressive Stress 319 319
Misconnection 290 290
Unintended System Motion 217 217
Activation Problem 191 191
Migration 187 196
Material Split, Cut or Torn 164 164
Loosening of Implant Not Related to Bone-Ingrowth 159 159
Positioning Problem 152 152
Difficult or Delayed Activation 149 149
Component Missing 144 144
Device Damaged by Another Device 137 137
Appropriate Term/Code Not Available 135 144
Separation Failure 123 123
Failure to Seal 122 122
Failure to Cut 116 116
Noise, Audible 110 110
Firing Problem 110 110
Therapy Delivered to Incorrect Body Area 102 102
Material Twisted/Bent 96 96
Material Puncture/Hole 86 86
Use of Device Problem 86 95

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35630 35639
No Consequences Or Impact To Patient 9469 9469
Hemorrhage/Bleeding 1229 1229
Hematoma 992 1001
Obstruction/Occlusion 762 762
Insufficient Information 670 670
Blood Loss 633 633
Unspecified Tissue Injury 599 599
Pseudoaneurysm 474 483
Foreign Body In Patient 420 420
Pain 406 406
Vascular Dissection 360 360
Tissue Damage 303 303
Extravasation 269 269
Occlusion 240 240
No Known Impact Or Consequence To Patient 185 185
Thrombosis/Thrombus 181 181
No Information 169 169
Stenosis 167 167
Unspecified Infection 145 145
Swelling/ Edema 121 121
Ischemia 120 120
Low Blood Pressure/ Hypotension 110 110
Perforation of Vessels 108 108
Intimal Dissection 104 104
Thrombosis 77 77
No Patient Involvement 76 76
Diminished Pulse Pressure 75 75
Death 62 62
Device Embedded In Tissue or Plaque 61 61
Retroperitoneal Hemorrhage 60 60
No Code Available 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 58 67
Failure of Implant 54 54
Perforation 48 48
Fistula 47 47
Embolism/Embolus 46 46
Numbness 45 45
Inflammation 43 43
Unspecified Vascular Problem 42 42
Laceration(s) 42 51
Anemia 41 41
Stroke/CVA 35 35
Bruise/Contusion 33 33
Shock 26 26
Renal Failure 24 24
Swelling 22 22
Embolism 22 22
Calcium Deposits/Calcification 19 19
Cardiac Arrest 19 19

Recalls
Manufacturer Recall Class Date Posted
1 Cordis US Corp II Jan-05-2024
2 TELEFLEX LLC II May-18-2023
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