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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
Product CodeHCG
Regulation Number 882.5950
Device Class 2


Premarket Reviews
ManufacturerDecision
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
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 2
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 1763 1763
2020 1753 1753
2021 2267 2267
2022 663 663
2023 569 569
2024 301 301

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 2172 2172
Failure to Advance 1966 1966
Premature Separation 1709 1709
Material Deformation 584 584
Separation Failure 483 483
Detachment of Device or Device Component 405 405
Difficult or Delayed Separation 306 306
Adverse Event Without Identified Device or Use Problem 306 306
Mechanical Problem 302 302
Fracture 265 265
Break 236 236
Migration 205 205
Stretched 188 188
Failure to Fold 145 145
Unraveled Material 96 96
Difficult to Advance 69 69
Material Twisted/Bent 64 64
Difficult to Remove 58 58
Device Damaged Prior to Use 54 54
Expulsion 52 52
Device-Device Incompatibility 34 34
Device Dislodged or Dislocated 30 30
Difficult or Delayed Positioning 26 26
Appropriate Term/Code Not Available 24 24
No Apparent Adverse Event 23 23
Migration or Expulsion of Device 22 22
Component Missing 21 21
Retraction Problem 19 19
Positioning Problem 19 19
Separation Problem 19 19
Device Fell 15 15
Fluid/Blood Leak 13 13
Device Markings/Labelling Problem 12 12
Insufficient Information 12 12
Unintended Movement 11 11
Premature Activation 11 11
Activation, Positioning or Separation Problem 10 10
Entrapment of Device 9 9
Activation Failure 9 9
Material Separation 8 8
Inadequacy of Device Shape and/or Size 8 8
Material Protrusion/Extrusion 6 6
Malposition of Device 6 6
Device Handling Problem 6 6
Inaccurate Information 6 6
Component Misassembled 5 5
Material Frayed 5 5
Collapse 4 4
Device Slipped 4 4
Device Difficult to Setup or Prepare 4 4
Deformation Due to Compressive Stress 4 4
Difficult or Delayed Activation 4 4
Material Split, Cut or Torn 4 4
Poor Visibility 4 4
Activation Problem 3 3
Contamination /Decontamination Problem 3 3
Corroded 3 3
Positioning Failure 3 3
Material Fragmentation 2 2
Unsealed Device Packaging 2 2
Material Too Rigid or Stiff 2 2
Patient-Device Incompatibility 2 2
Defective Device 2 2
Incomplete or Missing Packaging 2 2
Use of Device Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Inadequate User Interface 2 2
No Visual Prompts/Feedback 2 2
Noise, Audible 1 1
Mechanical Jam 1 1
Output Problem 1 1
Device Contaminated at the User Facility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Device Damaged by Another Device 1 1
Environmental Compatibility Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Failure to Read Input Signal 1 1
Particulates 1 1
Peeled/Delaminated 1 1
Poor Quality Image 1 1
Nonstandard Device 1 1
Unintended Collision 1 1
Difficult to Insert 1 1
Unintended Ejection 1 1
Difficult to Flush 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Discolored 1 1
Electrical /Electronic Property Problem 1 1
Crack 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4094 4094
No Consequences Or Impact To Patient 3359 3359
No Known Impact Or Consequence To Patient 102 102
No Patient Involvement 82 82
Aneurysm 57 57
Thrombosis/Thrombus 54 54
Foreign Body In Patient 52 52
Ruptured Aneurysm 40 40
Insufficient Information 38 38
Ischemia Stroke 37 37
Intracranial Hemorrhage 29 29
Stroke/CVA 28 28
Rupture 26 26
Hemorrhage/Bleeding 24 24
Device Embedded In Tissue or Plaque 20 20
Thromboembolism 17 17
Obstruction/Occlusion 17 17
Headache 17 17
Muscle Weakness 14 14
Vasoconstriction 14 14
Hydrocephalus 14 14
Unspecified Infection 13 13
Paresis 11 11
Thrombosis 11 11
Hematoma 11 11
Perforation 10 10
Embolism/Embolus 10 10
Stenosis 10 10
Thrombus 9 9
Perforation of Vessels 9 9
Death 9 9
Fever 8 8
Ischemia 8 8
Visual Impairment 8 8
Cerebral Edema 8 8
Convulsion/Seizure 8 8
Unspecified Nervous System Problem 8 8
Swelling/ Edema 7 7
Paralysis 7 7
Dysphasia 7 7
Cognitive Changes 7 7
Inflammation 7 7
High Blood Pressure/ Hypertension 6 6
Extravasation 6 6
Cardiac Arrest 6 6
Injury 6 6
Loss of Vision 5 5
Visual Disturbances 5 5
Patient Problem/Medical Problem 5 5
Neurological Deficit/Dysfunction 5 5
Neuropathy 5 5
Occlusion 4 4
Transient Ischemic Attack 4 4
Abscess 4 4
Infarction, Cerebral 4 4
Hemorrhage, Subarachnoid 4 4
Fistula 4 4
Foreign Body Reaction 4 4
Vascular Dissection 4 4
Coma 4 4
Speech Disorder 4 4
Hemorrhagic Stroke 4 4
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Foreign Body Embolism 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Blood Loss 3 3
Pseudoaneurysm 3 3
Dizziness 3 3
Failure of Implant 3 3
Aspiration/Inhalation 3 3
Pain 3 3
Necrosis 3 3
Nausea 2 2
Shock 2 2
Blurred Vision 2 2
Abdominal Pain 2 2
Pulmonary Emphysema 2 2
Hemoptysis 2 2
Cyst(s) 2 2
Fatigue 2 2
Great Vessel Perforation 2 2
Therapeutic Response, Decreased 2 2
Loss of consciousness 2 2
Irritability 2 2
Confusion/ Disorientation 2 2
Gastrointestinal Hemorrhage 2 2
Heart Failure/Congestive Heart Failure 2 2
Cough 1 1
Respiratory Insufficiency 1 1
Cancer 1 1
No Information 1 1
Epilepsy 1 1
Vascular System (Circulation), Impaired 1 1
Encephalitis 1 1
Chest Tightness/Pressure 1 1
Respiratory Failure 1 1
Sleep Dysfunction 1 1
Decreased Sensitivity 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BALT USA, LLC II Feb-08-2024
2 BALT USA, LLC II Oct-20-2022
3 BALT USA, LLC II Sep-06-2022
4 BALT USA, LLC II Feb-22-2022
5 Codman & Shurtleff Inc II Aug-15-2019
6 Micro Therapeutics, Inc. II Jun-13-2022
7 Microvention, Inc. II Feb-27-2020
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