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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, vascular, for promoting embolization
Regulation Description Vascular embolization device.
Product CodeKRD
Regulation Number 870.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ABK BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTIO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTVENTIVE MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAIT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, S.A.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANYON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMBOLIC ACCELERATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
EMBOLIZATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU YANGSHUN MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K240261  Siege Vascular Plug (SVP2.5-0.021); Siege Vascular ...
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
OBSIDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
OKAMI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1167 1167
2021 1444 1445
2022 1498 1501
2023 1371 1372
2024 1535 1541
2025 1597 1597
2026 1029 1029

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Failure 1972 1976
Detachment of Device or Device Component 1342 1344
Stretched 1173 1174
Physical Resistance/Sticking 1169 1170
Adverse Event Without Identified Device or Use Problem 1049 1050
Premature Separation 880 882
Failure to Advance 793 793
Break 658 658
Material Deformation 435 435
Difficult to Advance 393 393
Migration 366 366
Entrapment of Device 345 345
Difficult to Remove 277 277
Premature Activation 260 260
Positioning Problem 183 183
Deformation Due to Compressive Stress 169 169
Migration or Expulsion of Device 165 165
Unraveled Material 161 161
Material Separation 136 136
Material Twisted/Bent 134 134
Packaging Problem 119 119
Difficult or Delayed Separation 115 115
Malposition of Device 114 114
Off-Label Use 111 111
Unintended Movement 110 110
Device Difficult to Setup or Prepare 103 103
Patient Device Interaction Problem 91 91
Activation Problem 85 85
Material Integrity Problem 82 82
Inadequacy of Device Shape and/or Size 80 80
Material Protrusion/Extrusion 74 74
Difficult or Delayed Positioning 66 66
Device-Device Incompatibility 58 58
Fracture 49 49
Difficult to Insert 44 44
No Apparent Adverse Event 43 43
Use of Device Problem 42 42
Positioning Failure 41 41
Therapy Delivered to Incorrect Body Area 39 39
Activation, Positioning or Separation Problem 39 39
Product Quality Problem 38 38
Material Rupture 38 38
Material Split, Cut or Torn 36 36
Separation Problem 33 33
Difficult to Fold, Unfold or Collapse 31 31
Retraction Problem 29 29
Leak/Splash 29 29
Component Missing 26 26
Fluid/Blood Leak 24 24
Improper or Incorrect Procedure or Method 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7201 7210
No Consequences Or Impact To Patient 577 578
No Known Impact Or Consequence To Patient 292 292
Aneurysm 290 290
Foreign Body In Patient 247 248
Insufficient Information 159 160
Pain 93 94
Obstruction/Occlusion 80 80
Hemorrhage/Blood Loss/Bleeding 80 80
Embolism/Embolus 71 71
Thromboembolism 71 71
No Code Available 71 71
Thrombosis/Thrombus 70 71
Intracranial Hemorrhage 62 63
Ruptured Aneurysm 59 59
Ischemia 53 53
Stroke/CVA 52 52
Device Embedded In Tissue or Plaque 47 47
Ischemia Stroke 46 46
Vasoconstriction 37 37
Necrosis 35 35
Abdominal Pain 31 31
Fever 31 31
Hematoma 31 31
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 29 30
Perforation of Vessels 27 27
Failure of Implant 27 27
Sepsis 25 25
Unspecified Infection 21 21
Low Blood Pressure/ Hypotension 20 20
Pseudoaneurysm 20 20
Inflammation 20 20
Paresis 19 20
Hypersensitivity/Allergic reaction 19 19
Renal Failure 18 18
Foreign Body Embolism 18 18
Swelling/ Edema 17 17
Heart Failure/Congestive Heart Failure 16 16
Vascular Dissection 16 16
Unspecified Tissue Injury 16 16
Fistula 16 16
Anemia 15 15
Pancreatitis 14 14
Arrhythmia 14 14
Muscle Weakness/Atrophy 14 14
Nerve Damage 14 15
Convulsion/Seizure 14 14
Cardiac Arrest 13 13
Diplopia/Double Vision 13 13
Reduced Blood Flow 13 13

Recalls
Manufacturer Recall Class Date Posted
1 BALT USA, LLC II Jun-18-2025
2 BALT USA, LLC II Feb-08-2024
3 Boston Scientific Corporation I Mar-27-2024
4 Cook Incorporated II May-14-2025
5 Cook Incorporated II Jun-06-2022
6 MICROVENTION INC. II Jul-28-2025
7 MICROVENTION INC. II Oct-27-2023
8 Microvention, Inc. II Feb-13-2020
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