Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 151 151

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 2140 2140
Failure to Advance 1963 1963
Premature Separation 1635 1635
Material Deformation 582 582
Separation Failure 475 475
Detachment of Device or Device Component 400 400
Mechanical Problem 302 302
Difficult or Delayed Separation 302 302
Adverse Event Without Identified Device or Use Problem 284 284
Fracture 251 251
Break 231 231
Migration 191 191
Stretched 176 176
Failure to Fold 142 142
Unraveled Material 90 90
Difficult to Advance 68 68
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 28 28
Difficult or Delayed Positioning 25 25
Appropriate Term/Code Not Available 24 24
No Apparent Adverse Event 23 23
Migration or Expulsion of Device 21 21
Retraction Problem 19 19
Positioning Problem 19 19
Separation Problem 19 19
Component Missing 18 18
Device Fell 15 15
Fluid/Blood Leak 13 13
Device Markings/Labelling Problem 12 12
Insufficient Information 12 12
Premature Activation 11 11
Activation, Positioning or Separation Problem 10 10
Unintended Movement 10 10
Activation Failure 9 9
Entrapment of Device 9 9
Material Separation 8 8
Inadequacy of Device Shape and/or Size 6 6
Material Protrusion/Extrusion 6 6
Device Handling Problem 6 6
Component Misassembled 5 5
Inaccurate Information 5 5
Malposition of Device 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
Poor Visibility 4 4
Material Split, Cut or Torn 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
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
Output Problem 1 1
Device Contaminated at the User Facility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Mechanical Jam 1 1
Environmental Compatibility Problem 1 1
Material Integrity Problem 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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3979 3979
No Consequences Or Impact To Patient 3359 3359
No Known Impact Or Consequence To Patient 102 102
No Patient Involvement 82 82
Aneurysm 52 52
Thrombosis/Thrombus 49 49
Foreign Body In Patient 40 40
Insufficient Information 38 38
Ischemia Stroke 35 35
Ruptured Aneurysm 34 34
Intracranial Hemorrhage 29 29
Stroke/CVA 27 27
Rupture 26 26
Hemorrhage/Bleeding 22 22
Device Embedded In Tissue or Plaque 20 20
Thromboembolism 17 17
Headache 17 17
Obstruction/Occlusion 16 16
Vasoconstriction 13 13
Unspecified Infection 12 12
Muscle Weakness 12 12
Thrombosis 11 11
Hematoma 11 11
Hydrocephalus 11 11
Embolism/Embolus 10 10
Stenosis 10 10
Paresis 10 10
Perforation 10 10
Thrombus 9 9
Death 9 9
Perforation of Vessels 9 9
Unspecified Nervous System Problem 8 8
Convulsion/Seizure 8 8
Fever 8 8
Visual Impairment 7 7
Inflammation 7 7
Cerebral Edema 7 7
Swelling/ Edema 7 7
Cognitive Changes 7 7
Dysphasia 6 6
Injury 6 6
Ischemia 6 6
High Blood Pressure/ Hypertension 6 6
Cardiac Arrest 6 6
Extravasation 5 5
Loss of Vision 5 5
Neurological Deficit/Dysfunction 5 5
Paralysis 5 5
Patient Problem/Medical Problem 5 5
Coma 4 4
Hemorrhagic Stroke 4 4
Neuropathy 4 4
Occlusion 4 4
Visual Disturbances 4 4
Transient Ischemic Attack 4 4
Infarction, Cerebral 4 4
Abscess 4 4
Hemorrhage, Subarachnoid 4 4
Fistula 4 4
Foreign Body Reaction 4 4
Failure of Implant 3 3
Aspiration/Inhalation 3 3
Pain 3 3
Necrosis 3 3
Speech Disorder 3 3
No Code Available 3 3
Foreign Body Embolism 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Dizziness 3 3
Vascular Dissection 3 3
Blood Loss 3 3
Pseudoaneurysm 2 2
Therapeutic Response, Decreased 2 2
Loss of consciousness 2 2
Great Vessel Perforation 2 2
Gastrointestinal Hemorrhage 2 2
Heart Failure/Congestive Heart Failure 2 2
Nausea 2 2
Shock 2 2
Abdominal Pain 2 2
Pulmonary Emphysema 2 2
Hemoptysis 2 2
Cyst(s) 2 2
Fatigue 2 2
Granuloma 1 1
Hemorrhage, Cerebral 1 1
Hyperplasia 1 1
Hypersensitivity/Allergic reaction 1 1
Encephalopathy 1 1
Facial Nerve Paralysis 1 1
Chemosis 1 1
Edema 1 1
Embolism 1 1
Air Embolism 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Tachycardia 1 1
Optical Nerve Damage 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
-
-