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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 21

MDR Year MDR Reports MDR Events
2021 7586 7589
2022 9457 9475
2023 13529 13540
2024 13762 13762
2025 12860 12862
2026 3464 3464

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 31054 31057
Material Separation 6348 6348
Improper or Incorrect Procedure or Method 2058 2058
Malposition of Device 2043 2043
Adverse Event Without Identified Device or Use Problem 1775 1777
Off-Label Use 1700 1701
Insufficient Device Problem Information 1664 1664
Defective Component 1660 1660
Difficult to Open or Close 1652 1653
Entrapment of Device 1386 1386
Failure to Fire 1273 1273
Patient Device Interaction Problem 1270 1270
Difficult to Remove 1246 1246
Activation, Positioning or Separation Problem 1140 1140
Mechanical Jam 1130 1130
Obstruction of Flow 981 981
Decrease in Pressure 950 950
Premature Activation 853 853
Material Rupture 802 802
Activation Failure 705 705
Difficult to Insert 702 702
Physical Resistance/Sticking 675 675
Failure to Advance 593 593
Material Deformation 581 581
Difficult to Advance 570 570
Break 470 471
Therapy Delivered to Incorrect Body Area 459 459
Activation Problem 425 425
Product Quality Problem 367 367
Misconnection 299 299
Migration 282 291
Deformation Due to Compressive Stress 279 279
Retraction Problem 266 266
Unintended System Motion 254 254
Loosening of Implant Not Related to Bone-Ingrowth 241 241
Failure to Seal 225 225
Detachment of Device or Device Component 202 203
Device Damaged by Another Device 171 171
Positioning Problem 161 161
Positioning Failure 158 158
Material Split, Cut or Torn 147 147
Difficult or Delayed Positioning 130 130
Difficult or Delayed Activation 114 114
Component Missing 111 111
Noise, Audible 105 105
Separation Failure 94 94
Material Puncture/Hole 94 94
Loose or Intermittent Connection 90 90
Unintended Movement 89 89
Failure to Cut 82 82

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53933 53951
Hemorrhage/Blood Loss/Bleeding 1628 1633
Obstruction/Occlusion 1082 1083
Hematoma 958 969
Unspecified Tissue Injury 863 863
Insufficient Information 768 769
Pseudoaneurysm 543 553
Vascular Dissection 504 506
Foreign Body In Patient 438 439
Pain 391 391
Thrombosis/Thrombus 378 379
Unspecified Infection 314 314
Extravasation 182 182
Swelling/ Edema 167 167
No Consequences Or Impact To Patient 153 153
Perforation of Vessels 145 145
Stenosis 132 132
Ischemia 132 133
Local Reaction 119 119
Low Blood Pressure/ Hypotension 89 89
Diminished Pulse Pressure 82 82
Unspecified Vascular Problem 73 73
Retroperitoneal Hemorrhage 70 70
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 66 77
Embolism/Embolus 63 63
Fistula 62 62
Failure of Implant 46 46
Laceration(s) 45 56
Numbness 44 44
Device Embedded In Tissue or Plaque 42 42
Anemia 38 38
Reduced Blood Flow 36 36
Stroke/CVA 35 35
Shock 35 35
Bruise/Contusion 33 33
Inflammation 28 28
Unspecified Heart Problem 25 25
Abscess 24 24
Cardiac Arrest 22 22
Renal Failure 22 22
Nerve Damage 21 21
Perforation 19 19
Aneurysm 19 19
Calcium Deposits/Calcification 18 18
Hypersensitivity/Allergic reaction 17 17
Tissue Damage 16 16
Pulmonary Embolism 14 14
High Blood Pressure/ Hypertension 14 14
Myocardial Infarction 13 14
Fatigue 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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