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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 10

MDR Year MDR Reports MDR Events
2021 7586 7589
2022 9457 9475
2023 13529 13540
2024 13762 13762
2025 12860 12862
2026 1412 1412

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 31020 31022
Material Separation 6110 6111
Improper or Incorrect Procedure or Method 2005 2005
Malposition of Device 1958 1958
Off-Label Use 1667 1668
Adverse Event Without Identified Device or Use Problem 1643 1645
Insufficient Information 1625 1625
Difficult to Open or Close 1550 1551
Defective Component 1359 1359
Entrapment of Device 1331 1331
Patient Device Interaction Problem 1276 1276
Difficult to Remove 1213 1214
Activation, Positioning or Separation Problem 1157 1159
Failure to Fire 1136 1136
Mechanical Jam 1027 1027
Obstruction of Flow 979 979
Decrease in Pressure 853 853
Material Rupture 714 714
Premature Activation 712 712
Activation Failure 706 706
Physical Resistance/Sticking 690 691
Difficult to Insert 685 685
Failure to Advance 556 556
Difficult to Advance 536 536
Break 514 517
Material Deformation 514 514
Therapy Delivered to Incorrect Body Area 376 376
Activation Problem 375 376
Product Quality Problem 369 371
Misconnection 296 296
Deformation Due to Compressive Stress 275 275
Migration 266 275
Retraction Problem 260 261
Unintended System Motion 249 249
Loosening of Implant Not Related to Bone-Ingrowth 238 238
Failure to Seal 229 229
Detachment of Device or Device Component 213 214
Device Damaged by Another Device 163 163
Positioning Failure 162 162
Positioning Problem 157 157
Material Split, Cut or Torn 147 147
Component Missing 119 119
Difficult or Delayed Positioning 117 117
Difficult or Delayed Activation 113 113
Noise, Audible 105 106
Separation Failure 95 95
Material Puncture/Hole 94 94
Therapeutic or Diagnostic Output Failure 90 95
Unintended Movement 87 87
Failure to Cut 81 81

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52252 52270
Hemorrhage/Bleeding 1550 1555
Obstruction/Occlusion 1041 1042
Hematoma 901 912
Unspecified Tissue Injury 831 831
Insufficient Information 752 753
Pseudoaneurysm 524 534
Vascular Dissection 475 477
Foreign Body In Patient 412 413
Pain 372 372
Thrombosis/Thrombus 331 332
Unspecified Infection 279 279
Extravasation 182 182
No Consequences Or Impact To Patient 153 153
Swelling/ Edema 147 147
Perforation of Vessels 140 140
Stenosis 131 131
Ischemia 124 125
Local Reaction 96 96
Low Blood Pressure/ Hypotension 84 84
Diminished Pulse Pressure 78 78
Unspecified Vascular Problem 73 73
Retroperitoneal Hemorrhage 67 67
Fistula 62 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 73
Embolism/Embolus 62 62
Failure of Implant 46 46
Laceration(s) 44 55
Device Embedded In Tissue or Plaque 42 42
Numbness 41 41
Anemia 38 38
Stroke/CVA 35 35
Bruise/Contusion 33 33
Shock 32 32
Inflammation 27 27
Unspecified Heart Problem 25 25
Abscess 24 24
Renal Failure 22 22
Cardiac Arrest 19 19
Nerve Damage 19 19
Aneurysm 19 19
Calcium Deposits/Calcification 18 18
Perforation 17 17
Tissue Damage 16 16
Hypersensitivity/Allergic reaction 14 14
Myocardial Infarction 13 14
Pulmonary Embolism 13 13
Fatigue 12 12
Discomfort 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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