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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 1
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 1
OBSIDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL
  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 1598 1598

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Failure 1525 1529
Detachment of Device or Device Component 1014 1016
Physical Resistance/Sticking 911 912
Stretched 908 909
Adverse Event Without Identified Device or Use Problem 841 842
Premature Separation 702 704
Failure to Advance 701 701
Break 534 534
Difficult to Advance 335 335
Material Deformation 327 327
Migration 261 262
Difficult to Remove 215 215
Entrapment of Device 208 208
Premature Activation 199 199
Migration or Expulsion of Device 141 141
Deformation Due to Compressive Stress 127 127
Positioning Problem 123 123
Material Separation 118 118
Unraveled Material 116 116
Difficult or Delayed Separation 98 98
Device Difficult to Setup or Prepare 95 95
Malposition of Device 94 94
Off-Label Use 93 93
Packaging Problem 92 92
Activation Problem 86 86
Material Integrity Problem 72 72
Unintended Movement 72 72
Inadequacy of Device Shape and/or Size 69 69
Material Twisted/Bent 64 64
Patient Device Interaction Problem 60 60
Material Protrusion/Extrusion 44 44
Positioning Failure 40 40
Device-Device Incompatibility 39 39
Fracture 38 38
No Apparent Adverse Event 38 38
Material Split, Cut or Torn 37 37
Material Rupture 36 36
Use of Device Problem 35 35
Difficult to Insert 35 35
Product Quality Problem 33 33
Difficult or Delayed Positioning 32 32
Therapy Delivered to Incorrect Body Area 32 32
Activation, Positioning or Separation Problem 32 32
Difficult to Fold, Unfold or Collapse 30 30
Separation Problem 29 29
Component Missing 19 19
Improper or Incorrect Procedure or Method 17 17
Retraction Problem 17 17
Human-Device Interface Problem 13 13
Device Dislodged or Dislocated 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6123 6132
Aneurysm 273 273
Foreign Body In Patient 195 196
Insufficient Information 145 146
Obstruction/Occlusion 74 74
Hemorrhage/Bleeding 71 71
Embolism/Embolus 66 66
Thromboembolism 65 65
Thrombosis/Thrombus 63 64
Pain 59 60
Ruptured Aneurysm 55 55
Intracranial Hemorrhage 52 53
Ischemia 49 49
Ischemia Stroke 45 45
Vasoconstriction 32 32
No Consequences Or Impact To Patient 32 32
Device Embedded In Tissue or Plaque 32 32
Necrosis 30 30
Hematoma 29 29
Failure of Implant 26 26
Abdominal Pain 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 25
Sepsis 23 23
Perforation of Vessels 22 22
Stroke/CVA 21 21
Fever 20 20
Unspecified Infection 20 20
Paresis 19 20
Foreign Body Embolism 18 18
Renal Failure 18 18
Inflammation 18 18
Hypersensitivity/Allergic reaction 17 17
Pseudoaneurysm 17 17
Fistula 16 16
Unspecified Tissue Injury 16 16
Low Blood Pressure/ Hypotension 16 16
Convulsion/Seizure 14 14
Pancreatitis 13 13
Nerve Damage 13 14
Swelling/ Edema 13 13
Cardiac Arrest 13 13
Heart Failure/Congestive Heart Failure 13 13
Numbness 12 12
Tachycardia 12 12
Cardiac Tamponade 12 12
Muscle Weakness 12 12
Anemia 12 12
Hemolysis 11 11
Arrhythmia 11 11
Ptosis 11 11

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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