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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)
2021 2022 2023 2024 2025 2026
17 11 18 22 18 2

MDR Year MDR Reports MDR Events
2021 7586 7589
2022 9457 9475
2023 13529 13540
2024 13762 13762
2025 12860 12862
2026 375 375

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 30985 30987
Material Separation 5997 5998
Improper or Incorrect Procedure or Method 1974 1974
Malposition of Device 1870 1870
Off-Label Use 1656 1657
Insufficient Information 1594 1594
Adverse Event Without Identified Device or Use Problem 1506 1508
Difficult to Open or Close 1490 1491
Entrapment of Device 1297 1297
Patient Device Interaction Problem 1275 1275
Defective Component 1222 1222
Difficult to Remove 1174 1175
Activation, Positioning or Separation Problem 1143 1145
Failure to Fire 1081 1081
Obstruction of Flow 976 976
Mechanical Jam 975 975
Decrease in Pressure 818 818
Material Rupture 681 681
Physical Resistance/Sticking 680 681
Activation Failure 679 679
Difficult to Insert 678 678
Premature Activation 655 655
Failure to Advance 536 536
Difficult to Advance 521 521
Break 496 499
Material Deformation 483 483
Product Quality Problem 365 367
Activation Problem 348 349
Therapy Delivered to Incorrect Body Area 332 332
Misconnection 296 296
Deformation Due to Compressive Stress 271 271
Retraction Problem 254 255
Unintended System Motion 245 245
Migration 245 254
Loosening of Implant Not Related to Bone-Ingrowth 236 236
Failure to Seal 217 217
Detachment of Device or Device Component 204 205
Positioning Failure 160 160
Positioning Problem 155 155
Device Damaged by Another Device 150 150
Material Split, Cut or Torn 142 142
Component Missing 117 117
Difficult or Delayed Activation 113 113
Difficult or Delayed Positioning 109 109
Noise, Audible 104 105
Separation Failure 94 94
Material Puncture/Hole 91 91
Therapeutic or Diagnostic Output Failure 87 92
Unintended Movement 84 84
Failure to Cut 81 81

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51463 51481
Hemorrhage/Bleeding 1461 1466
Obstruction/Occlusion 1012 1013
Hematoma 865 876
Unspecified Tissue Injury 804 804
Insufficient Information 744 745
Pseudoaneurysm 486 496
Vascular Dissection 455 457
Foreign Body In Patient 401 402
Pain 359 359
Thrombosis/Thrombus 288 289
Unspecified Infection 246 246
Extravasation 181 181
No Consequences Or Impact To Patient 153 153
Swelling/ Edema 145 145
Perforation of Vessels 135 135
Stenosis 125 125
Ischemia 119 120
Local Reaction 95 95
Low Blood Pressure/ Hypotension 84 84
Diminished Pulse Pressure 75 75
Unspecified Vascular Problem 70 70
Retroperitoneal Hemorrhage 64 64
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 73
Embolism/Embolus 58 58
Fistula 54 54
Failure of Implant 46 46
Laceration(s) 43 54
Device Embedded In Tissue or Plaque 42 42
Numbness 41 41
Anemia 38 38
Stroke/CVA 35 35
Bruise/Contusion 30 30
Shock 28 28
Inflammation 27 27
Abscess 24 24
Unspecified Heart Problem 24 24
Renal Failure 19 19
Nerve Damage 19 19
Calcium Deposits/Calcification 18 18
Cardiac Arrest 18 18
Aneurysm 18 18
Perforation 17 17
Tissue Damage 16 16
Hypersensitivity/Allergic reaction 14 14
Myocardial Infarction 13 14
Discomfort 12 12
Fatigue 12 12
Pulmonary Embolism 12 12
High Blood Pressure/ Hypertension 12 12

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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