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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device device, hemostasis, vascular
Product CodeMGB
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
10 17 11 18 22 11

MDR Year MDR Reports MDR Events
2020 5927 5927
2021 7586 7586
2022 9457 9466
2023 13529 13529
2024 13761 13761
2025 5750 5750

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 29787 29787
Material Separation 6066 6066
Improper or Incorrect Procedure or Method 2184 2184
Malposition of Device 2124 2124
Insufficient Information 1684 1684
Off-Label Use 1568 1568
Adverse Event Without Identified Device or Use Problem 1543 1543
Patient Device Interaction Problem 1427 1427
Difficult to Open or Close 1378 1378
Activation, Positioning or Separation Problem 1311 1311
Entrapment of Device 1308 1308
Difficult to Remove 1158 1158
Obstruction of Flow 1050 1050
Failure to Fire 864 864
Decrease in Pressure 769 769
Mechanical Jam 759 759
Difficult to Insert 746 746
Physical Resistance/Sticking 710 710
Activation Failure 675 675
Defective Component 622 622
Material Rupture 593 593
Break 561 561
Failure to Advance 552 552
Material Deformation 509 509
Premature Activation 500 500
Difficult to Advance 489 489
Product Quality Problem 412 412
Detachment of Device or Device Component 330 330
Deformation Due to Compressive Stress 295 295
Misconnection 290 290
Retraction Problem 282 282
Activation Problem 276 276
Unintended System Motion 246 246
Positioning Failure 230 230
Migration 230 239
Loosening of Implant Not Related to Bone-Ingrowth 215 215
Therapy Delivered to Incorrect Body Area 204 204
Failure to Seal 177 177
Positioning Problem 147 147
Material Split, Cut or Torn 145 145
Device Damaged by Another Device 140 140
Difficult or Delayed Activation 130 130
Component Missing 125 125
Noise, Audible 108 108
Separation Failure 99 99
Failure to Cut 93 93
Material Puncture/Hole 92 92
Difficult or Delayed Positioning 82 82
Unintended Movement 81 81
Therapeutic or Diagnostic Output Failure 79 79

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45059 45068
No Consequences Or Impact To Patient 4568 4568
Hemorrhage/Bleeding 1402 1402
Hematoma 971 980
Obstruction/Occlusion 916 916
Unspecified Tissue Injury 707 707
Insufficient Information 702 702
Pseudoaneurysm 516 525
Vascular Dissection 423 423
Foreign Body In Patient 418 418
Pain 391 391
Blood Loss 262 262
Extravasation 246 246
Thrombosis/Thrombus 228 228
Unspecified Infection 215 215
Tissue Damage 189 189
Stenosis 151 151
Occlusion 144 144
Ischemia 131 131
Swelling/ Edema 130 130
Perforation of Vessels 123 123
Low Blood Pressure/ Hypotension 99 99
Diminished Pulse Pressure 78 78
Local Reaction 69 69
Retroperitoneal Hemorrhage 65 65
Unspecified Vascular Problem 63 63
Intimal Dissection 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 70
Failure of Implant 59 59
Thrombosis 59 59
Embolism/Embolus 54 54
Fistula 52 52
Device Embedded In Tissue or Plaque 49 49
Numbness 44 44
No Information 43 43
No Patient Involvement 42 42
No Known Impact Or Consequence To Patient 42 42
Death 42 42
Laceration(s) 42 51
Anemia 42 42
Inflammation 41 41
Stroke/CVA 38 38
Perforation 36 36
Bruise/Contusion 34 34
Shock 29 29
No Code Available 23 23
Aneurysm 22 22
Renal Failure 22 22
Nerve Damage 21 21
Cardiac Arrest 20 20

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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