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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
CANYON MEDICAL, INC.
  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 1
NUVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
OBSIDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
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
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 1701 1705
Detachment of Device or Device Component 1076 1078
Physical Resistance/Sticking 1055 1056
Stretched 1002 1003
Adverse Event Without Identified Device or Use Problem 934 935
Premature Separation 820 822
Failure to Advance 770 770
Break 602 602
Material Deformation 393 393
Difficult to Advance 363 363
Migration 313 313
Difficult to Remove 248 248
Premature Activation 221 221
Entrapment of Device 214 214
Migration or Expulsion of Device 146 146
Deformation Due to Compressive Stress 129 129
Unraveled Material 128 128
Positioning Problem 126 126
Material Separation 124 124
Packaging Problem 113 113
Difficult or Delayed Separation 107 107
Malposition of Device 106 106
Device Difficult to Setup or Prepare 100 100
Off-Label Use 99 99
Unintended Movement 98 98
Activation Problem 83 83
Inadequacy of Device Shape and/or Size 79 79
Material Integrity Problem 75 75
Patient Device Interaction Problem 73 73
Material Twisted/Bent 63 63
Material Protrusion/Extrusion 56 56
Difficult or Delayed Positioning 49 49
Fracture 44 44
Device-Device Incompatibility 42 42
No Apparent Adverse Event 40 40
Positioning Failure 40 40
Use of Device Problem 40 40
Therapy Delivered to Incorrect Body Area 39 39
Material Rupture 38 38
Difficult to Insert 37 37
Material Split, Cut or Torn 36 36
Product Quality Problem 35 35
Activation, Positioning or Separation Problem 35 35
Difficult to Fold, Unfold or Collapse 31 31
Separation Problem 29 29
Component Missing 24 24
Retraction Problem 23 23
Fluid/Blood Leak 22 22
Leak/Splash 21 21
Improper or Incorrect Procedure or Method 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6918 6927
Aneurysm 273 273
Foreign Body In Patient 232 233
Insufficient Information 155 156
Obstruction/Occlusion 75 75
Pain 73 74
Hemorrhage/Blood Loss/Bleeding 71 71
Embolism/Embolus 69 69
Thrombosis/Thrombus 67 68
Thromboembolism 65 65
Ruptured Aneurysm 59 59
Intracranial Hemorrhage 58 59
Ischemia 51 51
Ischemia Stroke 45 45
Vasoconstriction 34 34
Device Embedded In Tissue or Plaque 33 33
No Consequences Or Impact To Patient 32 32
Necrosis 32 32
Hematoma 29 29
Failure of Implant 27 27
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 27 28
Abdominal Pain 25 25
Sepsis 23 23
Fever 22 22
Perforation of Vessels 22 22
Stroke/CVA 21 21
Unspecified Infection 20 20
Inflammation 19 19
Paresis 19 20
Renal Failure 18 18
Foreign Body Embolism 18 18
Pseudoaneurysm 17 17
Hypersensitivity/Allergic reaction 17 17
Unspecified Tissue Injury 16 16
Fistula 16 16
Heart Failure/Congestive Heart Failure 16 16
Low Blood Pressure/ Hypotension 16 16
Convulsion/Seizure 14 14
Swelling/ Edema 14 14
Anemia 14 14
Reduced Blood Flow 13 13
Arrhythmia 13 13
Pancreatitis 13 13
Muscle Weakness/Atrophy 13 13
Nerve Damage 13 14
Diplopia/Double Vision 13 13
Cardiac Arrest 13 13
Tachycardia 12 12
Cardiac Tamponade 12 12
Vascular Dissection 12 12

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
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