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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
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMBOLIC ACCELERATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU YANGSHUN MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, 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 2
OBSIDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
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 1444
2022 1498 1498
2023 1374 1374
2024 1535 1535
2025 249 249

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Failure 1530 1530
Detachment of Device or Device Component 1152 1152
Stretched 883 883
Physical Resistance/Sticking 754 754
Adverse Event Without Identified Device or Use Problem 736 736
Failure to Advance 585 585
Premature Separation 539 539
Break 441 441
Entrapment of Device 327 327
Difficult to Advance 315 315
Material Deformation 273 273
Migration 254 254
Premature Activation 202 202
Difficult to Remove 185 185
Deformation Due to Compressive Stress 164 164
Positioning Problem 158 158
Migration or Expulsion of Device 143 143
Material Twisted/Bent 129 129
Unraveled Material 121 121
Material Separation 100 100
Device Difficult to Setup or Prepare 95 95
Off-Label Use 88 88
Difficult or Delayed Separation 80 80
Malposition of Device 73 73
Packaging Problem 72 72
Material Integrity Problem 70 70
Patient Device Interaction Problem 64 64
Unintended Movement 64 64
Activation Problem 60 60
Inadequacy of Device Shape and/or Size 55 55
Material Protrusion/Extrusion 51 51
Device-Device Incompatibility 46 46
Difficult or Delayed Positioning 44 44
Positioning Failure 40 40
Fracture 40 40
Activation, Positioning or Separation Problem 36 36
Material Rupture 35 35
Difficult to Insert 34 34
Material Split, Cut or Torn 32 32
Product Quality Problem 30 30
Use of Device Problem 29 29
No Apparent Adverse Event 26 26
Improper or Incorrect Procedure or Method 23 23
Therapy Delivered to Incorrect Body Area 22 22
Difficult to Fold, Unfold or Collapse 21 21
Component Missing 21 21
Separation Problem 20 20
Human-Device Interface Problem 18 18
Retraction Problem 16 16
Activation Failure 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5128 5128
No Consequences Or Impact To Patient 577 578
No Known Impact Or Consequence To Patient 292 292
Aneurysm 282 282
Foreign Body In Patient 149 149
Insufficient Information 121 121
No Code Available 71 71
Thromboembolism 70 70
Obstruction/Occlusion 66 66
Pain 60 60
Hemorrhage/Bleeding 56 56
Thrombosis/Thrombus 55 55
Intracranial Hemorrhage 51 51
Ruptured Aneurysm 51 51
Embolism/Embolus 51 51
Stroke/CVA 48 48
Device Embedded In Tissue or Plaque 44 44
Ischemia Stroke 44 44
Ischemia 35 35
Vasoconstriction 32 32
Hematoma 26 26
Necrosis 26 26
Perforation of Vessels 25 25
Abdominal Pain 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Failure of Implant 20 20
Hypersensitivity/Allergic reaction 19 19
Pseudoaneurysm 18 18
Sepsis 18 18
Paresis 17 17
Inflammation 17 17
Foreign Body Embolism 16 16
Fistula 15 15
Unspecified Infection 15 15
Fever 15 15
Unspecified Tissue Injury 15 15
Convulsion/Seizure 14 14
Low Blood Pressure/ Hypotension 14 14
Heart Failure/Congestive Heart Failure 12 12
Cardiac Tamponade 11 11
Nerve Damage 11 11
Swelling/ Edema 11 11
Muscle Weakness 11 11
Ptosis 11 11
Hydrocephalus 10 10
Arrhythmia 10 10
Renal Failure 10 10
Tachycardia 10 10
Cardiac Arrest 10 10
Anemia 10 10

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