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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)
2020 2021 2022 2023 2024 2025
10 17 11 18 22 15

MDR Year MDR Reports MDR Events
2020 5927 5927
2021 7586 7589
2022 9457 9475
2023 13529 13540
2024 13762 13762
2025 12284 12286

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 32780 32782
Material Separation 6624 6625
Malposition of Device 2331 2331
Improper or Incorrect Procedure or Method 2328 2328
Insufficient Information 1834 1834
Off-Label Use 1711 1712
Adverse Event Without Identified Device or Use Problem 1708 1710
Difficult to Open or Close 1559 1560
Patient Device Interaction Problem 1544 1544
Entrapment of Device 1432 1432
Activation, Positioning or Separation Problem 1382 1384
Difficult to Remove 1274 1275
Obstruction of Flow 1129 1129
Failure to Fire 1127 1127
Defective Component 1093 1093
Mechanical Jam 1001 1001
Decrease in Pressure 864 864
Difficult to Insert 829 829
Activation Failure 791 791
Physical Resistance/Sticking 748 749
Material Rupture 689 689
Material Deformation 636 636
Premature Activation 627 627
Failure to Advance 626 626
Break 591 594
Difficult to Advance 563 563
Product Quality Problem 432 434
Detachment of Device or Device Component 357 358
Activation Problem 347 348
Therapy Delivered to Incorrect Body Area 323 323
Deformation Due to Compressive Stress 309 309
Retraction Problem 308 309
Misconnection 290 290
Unintended System Motion 261 261
Migration 251 260
Positioning Failure 236 236
Loosening of Implant Not Related to Bone-Ingrowth 231 231
Failure to Seal 211 211
Material Split, Cut or Torn 174 174
Positioning Problem 163 163
Device Damaged by Another Device 162 162
Component Missing 137 137
Difficult or Delayed Activation 136 136
Difficult or Delayed Positioning 121 121
Noise, Audible 111 112
Material Puncture/Hole 107 107
Failure to Cut 104 104
Separation Failure 103 103
Unintended Movement 95 95
Material Twisted/Bent 93 93

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51011 51029
No Consequences Or Impact To Patient 4568 4568
Hemorrhage/Bleeding 1579 1584
Hematoma 1050 1061
Obstruction/Occlusion 1009 1010
Unspecified Tissue Injury 780 780
Insufficient Information 751 752
Pseudoaneurysm 573 583
Vascular Dissection 467 469
Foreign Body In Patient 441 442
Pain 423 423
Thrombosis/Thrombus 273 274
Blood Loss 262 262
Unspecified Infection 253 253
Extravasation 247 247
Tissue Damage 189 189
Stenosis 164 164
Ischemia 149 150
Swelling/ Edema 146 146
Occlusion 144 144
Perforation of Vessels 135 135
Low Blood Pressure/ Hypotension 108 108
Diminished Pulse Pressure 86 86
Local Reaction 77 77
Unspecified Vascular Problem 70 70
Retroperitoneal Hemorrhage 68 68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 63 74
Intimal Dissection 61 61
Failure of Implant 59 59
Fistula 59 59
Thrombosis 59 59
Embolism/Embolus 58 58
Device Embedded In Tissue or Plaque 54 54
Numbness 49 49
Anemia 46 46
No Information 43 43
Laceration(s) 43 54
Death 42 42
No Known Impact Or Consequence To Patient 42 42
No Patient Involvement 42 42
Inflammation 41 41
Stroke/CVA 41 41
Perforation 38 38
Bruise/Contusion 34 34
Shock 31 31
Abscess 25 25
Renal Failure 24 24
No Code Available 23 23
Nerve Damage 22 22
Aneurysm 22 22

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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