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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 3
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
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 1
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 884 884

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Failure 1943 1947
Detachment of Device or Device Component 1330 1332
Stretched 1161 1162
Physical Resistance/Sticking 1142 1143
Adverse Event Without Identified Device or Use Problem 1015 1016
Premature Separation 864 866
Failure to Advance 792 792
Break 644 644
Material Deformation 422 422
Difficult to Advance 389 389
Migration 358 358
Entrapment of Device 344 344
Difficult to Remove 269 269
Premature Activation 257 257
Positioning Problem 180 180
Deformation Due to Compressive Stress 169 169
Migration or Expulsion of Device 163 163
Unraveled Material 160 160
Material Separation 136 136
Material Twisted/Bent 135 135
Packaging Problem 117 117
Difficult or Delayed Separation 112 112
Malposition of Device 109 109
Off-Label Use 109 109
Unintended Movement 109 109
Device Difficult to Setup or Prepare 103 103
Patient Device Interaction Problem 89 89
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 65 65
Device-Device Incompatibility 57 57
Fracture 49 49
Difficult to Insert 43 43
Use of Device Problem 42 42
No Apparent Adverse Event 41 41
Positioning Failure 41 41
Therapy Delivered to Incorrect Body Area 39 39
Activation, Positioning or Separation Problem 39 39
Material Rupture 38 38
Product Quality Problem 37 37
Material Split, Cut or Torn 36 36
Separation Problem 33 33
Difficult to Fold, Unfold or Collapse 31 31
Leak/Splash 28 28
Retraction Problem 26 26
Component Missing 26 26
Improper or Incorrect Procedure or Method 23 23
Fluid/Blood Leak 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7098 7107
No Consequences Or Impact To Patient 577 578
No Known Impact Or Consequence To Patient 292 292
Aneurysm 290 290
Foreign Body In Patient 242 243
Insufficient Information 155 156
Pain 85 86
Obstruction/Occlusion 79 79
Hemorrhage/Blood Loss/Bleeding 75 75
No Code Available 71 71
Thromboembolism 70 70
Embolism/Embolus 70 70
Thrombosis/Thrombus 67 68
Intracranial Hemorrhage 62 63
Ruptured Aneurysm 59 59
Ischemia 52 52
Stroke/CVA 51 51
Device Embedded In Tissue or Plaque 47 47
Ischemia Stroke 46 46
Vasoconstriction 36 36
Necrosis 32 32
Hematoma 30 30
Abdominal Pain 27 27
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 27 28
Failure of Implant 27 27
Perforation of Vessels 26 26
Sepsis 23 23
Fever 22 22
Unspecified Infection 21 21
Inflammation 20 20
Pseudoaneurysm 19 19
Paresis 19 20
Hypersensitivity/Allergic reaction 19 19
Foreign Body Embolism 18 18
Low Blood Pressure/ Hypotension 18 18
Renal Failure 18 18
Unspecified Tissue Injury 16 16
Fistula 16 16
Heart Failure/Congestive Heart Failure 16 16
Swelling/ Edema 14 14
Convulsion/Seizure 14 14
Nerve Damage 14 15
Vascular Dissection 14 14
Muscle Weakness/Atrophy 14 14
Anemia 14 14
Pancreatitis 13 13
Arrhythmia 13 13
Reduced Blood Flow 13 13
Diplopia/Double Vision 13 13
Cardiac Arrest 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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