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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, neurovascular embolization
Regulation Description Neurovascular embolization device.
Product CodeHCG
Regulation Number 882.5950
Device Class 2


Premarket Reviews
ManufacturerDecision
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 3
KANEKA MEDICAL AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
KANEKA PHARMA AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT NEUROTECH (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
STRYKER NEUROVSCULAR
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1753 1753
2021 2267 2267
2022 663 663
2023 569 569
2024 557 557
2025 211 211

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Separation 1668 1668
Physical Resistance/Sticking 1642 1642
Failure to Advance 1429 1429
Material Deformation 438 438
Separation Failure 376 376
Fracture 314 314
Adverse Event Without Identified Device or Use Problem 295 295
Detachment of Device or Device Component 283 283
Difficult or Delayed Separation 274 274
Migration 222 222
Mechanical Problem 216 216
Break 143 143
Stretched 138 138
Failure to Fold 111 111
Unraveled Material 89 89
Expulsion 62 62
Difficult to Advance 61 61
Difficult to Remove 38 38
Material Twisted/Bent 28 28
Device Dislodged or Dislocated 25 25
No Apparent Adverse Event 23 23
Component Missing 22 22
Appropriate Term/Code Not Available 18 18
Device-Device Incompatibility 17 17
Positioning Problem 15 15
Migration or Expulsion of Device 14 14
Separation Problem 13 13
Fluid/Blood Leak 13 13
Insufficient Information 12 12
Difficult or Delayed Positioning 12 12
Device Markings/Labelling Problem 10 10
Activation Failure 9 9
Retraction Problem 9 9
Activation, Positioning or Separation Problem 9 9
Premature Activation 9 9
Entrapment of Device 8 8
Unintended Movement 8 8
Inadequacy of Device Shape and/or Size 7 7
Inaccurate Information 6 6
Malposition of Device 5 5
Material Separation 5 5
Poor Visibility 4 4
Device Difficult to Setup or Prepare 4 4
Device Slipped 4 4
Material Frayed 4 4
Component Misassembled 3 3
No Visual Prompts/Feedback 3 3
Material Split, Cut or Torn 3 3
Corroded 3 3
Deformation Due to Compressive Stress 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4479 4479
No Consequences Or Impact To Patient 1844 1844
Foreign Body In Patient 67 67
Thrombosis/Thrombus 63 63
Aneurysm 52 52
Ruptured Aneurysm 44 44
Insufficient Information 43 43
Ischemia Stroke 43 43
Stroke/CVA 32 32
Hemorrhage/Bleeding 29 29
Intracranial Hemorrhage 28 28
No Known Impact Or Consequence To Patient 21 21
Obstruction/Occlusion 21 21
Rupture 20 20
Muscle Weakness 19 19
Device Embedded In Tissue or Plaque 18 18
Headache 17 17
Hydrocephalus 15 15
Thromboembolism 15 15
Vasoconstriction 15 15
Stenosis 13 13
Paresis 12 12
Paralysis 12 12
Embolism/Embolus 12 12
Hematoma 11 11
Ischemia 10 10
Visual Impairment 9 9
Cerebral Edema 9 9
Swelling/ Edema 8 8
Perforation of Vessels 8 8
Inflammation 8 8
Convulsion/Seizure 8 8
Unspecified Nervous System Problem 8 8
Perforation 7 7
Speech Disorder 7 7
Cognitive Changes 7 7
Failure of Implant 6 6
Loss of Vision 6 6
Hemorrhagic Stroke 6 6
Dysphasia 6 6
Extravasation 6 6
Visual Disturbances 6 6
Vascular Dissection 5 5
Unspecified Infection 5 5
Neuropathy 5 5
Thrombosis 5 5
Transient Ischemic Attack 5 5
Coma 4 4
Cardiac Arrest 4 4
Foreign Body Reaction 4 4

Recalls
Manufacturer Recall Class Date Posted
1 BALT USA, LLC II Jun-18-2025
2 BALT USA, LLC II Feb-08-2024
3 BALT USA, LLC II Oct-20-2022
4 BALT USA, LLC II Sep-06-2022
5 BALT USA, LLC II Feb-22-2022
6 Micro Therapeutics, Inc. II Jun-13-2022
7 Microvention, Inc. II Feb-27-2020
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