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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
BLOCKADE MEDICAL, LLC (D.B.A. BALT USA)
  SUBSTANTIALLY EQUIVALENT 1
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
MICROPORT NEUROTECH (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPARTAN MICRO, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WALLABY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2058 2058
2019 1763 1763
2020 1753 1753
2021 2267 2267
2022 663 663
2023 386 386

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 2587 2587
Physical Resistance/Sticking 2395 2395
Premature Separation 1588 1588
Material Deformation 644 644
Separation Failure 565 565
Detachment of Device or Device Component 469 469
Mechanical Problem 384 384
Break 374 374
Adverse Event Without Identified Device or Use Problem 347 347
Physical Resistance 330 330
Difficult or Delayed Separation 313 313
Fracture 225 225
Stretched 213 213
Detachment Of Device Component 208 208
Migration 190 190
Failure to Fold 181 181
Device Damaged Prior to Use 147 147
Unraveled Material 106 106
Difficult to Advance 102 102
Material Twisted/Bent 94 94
Kinked 90 90
Difficult to Remove 83 83
Device Handling Problem 82 82
Mechanical Jam 79 79
Difficult or Delayed Activation 60 60
Device Operates Differently Than Expected 54 54
Device-Device Incompatibility 52 52
Premature Activation 51 51
Migration or Expulsion of Device 50 50
Retraction Problem 47 47
Expulsion 42 42
Device Dislodged or Dislocated 36 36
Out-Of-Box Failure 36 36
Difficult or Delayed Positioning 34 34
Inadequacy of Device Shape and/or Size 32 32
Bent 29 29
Positioning Problem 26 26
No Apparent Adverse Event 26 26
Device Fell 25 25
Appropriate Term/Code Not Available 24 24
Unintended Movement 22 22
Separation Problem 22 22
Deformation Due to Compressive Stress 21 21
Positioning Failure 20 20
Activation, Positioning or Separation Problem 16 16
Material Protrusion/Extrusion 16 16
Component Missing 15 15
Fluid/Blood Leak 15 15
Material Separation 13 13
Material Too Rigid or Stiff 13 13
Difficult To Position 13 13
Insufficient Information 13 13
Device Markings/Labelling Problem 12 12
Malposition of Device 11 11
Entrapment of Device 11 11
Activation Failure 9 9
Defective Device 8 8
Patient-Device Incompatibility 7 7
Collapse 6 6
Material Frayed 6 6
Device Difficult to Setup or Prepare 5 5
Component Misassembled 5 5
Inadequate User Interface 5 5
Material Split, Cut or Torn 4 4
Activation Problem 4 4
Poor Visibility 4 4
Inaccurate Information 4 4
Device Slipped 4 4
Folded 3 3
Contamination /Decontamination Problem 3 3
Leak/Splash 3 3
Contamination 3 3
Corroded 3 3
Device Contamination with Chemical or Other Material 3 3
Material Integrity Problem 3 3
Difficult to Open or Remove Packaging Material 2 2
Noise, Audible 2 2
Physical Property Issue 2 2
Knotted 2 2
Material Fragmentation 2 2
Particulates 2 2
Chemical Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Device Contamination with Body Fluid 1 1
Sticking 1 1
Failure to Read Input Signal 1 1
Failure to Select Signal 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Dull, Blunt 1 1
High Sensing Threshold 1 1
Wrinkled 1 1
Biocompatibility 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Poor Quality Image 1 1
Unintended Collision 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5031 5031
No Clinical Signs, Symptoms or Conditions 3714 3714
No Patient Involvement 240 240
No Known Impact Or Consequence To Patient 175 175
Aneurysm 69 69
Rupture 41 41
Thrombosis/Thrombus 39 39
Thrombus 36 36
Insufficient Information 33 33
Intracranial Hemorrhage 31 31
Headache 30 30
Ischemia Stroke 30 30
Foreign Body In Patient 28 28
Stroke/CVA 28 28
Ruptured Aneurysm 27 27
Ischemia 26 26
Device Embedded In Tissue or Plaque 23 23
Thrombosis 23 23
Hemorrhage/Bleeding 22 22
Death 19 19
Thromboembolism 17 17
Neurological Deficit/Dysfunction 14 14
Vasoconstriction 13 13
Weakness 13 13
Patient Problem/Medical Problem 12 12
Muscle Weakness 12 12
Unspecified Infection 12 12
Perforation 11 11
Obstruction/Occlusion 11 11
Embolism/Embolus 10 10
Paresis 10 10
Hemorrhage, Subarachnoid 9 9
Occlusion 9 9
Infarction, Cerebral 9 9
Fever 8 8
Perforation of Vessels 8 8
No Code Available 8 8
Dizziness 8 8
Stenosis 7 7
Hydrocephalus 7 7
Cerebral Edema 7 7
Convulsion/Seizure 7 7
Unspecified Nervous System Problem 7 7
Swelling/ Edema 7 7
Visual Impairment 7 7
Hematoma 7 7
Cardiac Arrest 6 6
Transient Ischemic Attack 6 6
High Blood Pressure/ Hypertension 6 6
Neuropathy 6 6
Inflammation 6 6
Dysphasia 6 6
Injury 6 6
Cognitive Changes 6 6
Lethargy 5 5
Numbness 5 5
Visual Disturbances 5 5
No Information 5 5
Extravasation 5 5
Foreign Body Reaction 4 4
Hemorrhage, Cerebral 4 4
Abscess 4 4
Paralysis 4 4
Loss of Vision 3 3
Pain 3 3
Embolism 3 3
Embolus 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Blood Loss 3 3
Great Vessel Perforation 2 2
Coma 2 2
Therapeutic Response, Decreased 2 2
Gastrointestinal Hemorrhage 2 2
Heart Failure/Congestive Heart Failure 2 2
Pulmonary Emphysema 2 2
Abdominal Pain 2 2
Aspiration/Inhalation 2 2
Bacterial Infection 2 2
Hemoptysis 2 2
Fatigue 2 2
Fistula 2 2
Nausea 2 2
Shock 2 2
Tachycardia 1 1
Pulmonary Dysfunction 1 1
Renal Failure 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Septic Shock 1 1
Blurred Vision 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Tissue Damage 1 1
Necrosis 1 1
Nerve Damage 1 1
Reocclusion 1 1
Optical Nerve Damage 1 1
Hypersensitivity/Allergic reaction 1 1
Myocardial Infarction 1 1

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