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
BIOCOMPATIBLES U.K. LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLOCKADE MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
BLOCKADE MEDICAL, LLC (D.B.A. BALT USA)
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
CODMAN & SHURTLEFF, INC
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 5
CODMAN AND SHURTLEFF, INC.
  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 4
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT NEUROTECH (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 20
MICRUS ENDOVASCULAR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 10
SPARTAN MICRO, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 9
WALLABY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1729 1729
2015 1598 1598
2016 1990 1990
2017 2494 2494
2018 2058 2058
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
Failure to Advance 4070 4070
Physical Resistance/Sticking 2436 2436
Physical Resistance 1873 1873
Premature Separation 1756 1756
Detachment Of Device Component 1357 1357
Adverse Event Without Identified Device or Use Problem 1206 1206
Stretched 877 877
Separation Failure 857 857
Break 844 844
Material Deformation 706 706
Premature Activation 661 661
Positioning Failure 660 660
Kinked 649 649
Detachment of Device or Device Component 587 587
Mechanical Problem 516 516
Device Operates Differently Than Expected 376 376
Difficult to Advance 376 376
Fracture 333 333
Difficult or Delayed Separation 322 322
Mechanical Jam 316 316
Migration or Expulsion of Device 301 301
Device Handling Problem 294 294
Device Damaged Prior to Use 259 259
Bent 246 246
Migration 217 217
Unraveled Material 209 209
Difficult to Remove 202 202
Failure to Fold 197 197
Retraction Problem 193 193
Out-Of-Box Failure 146 146
Difficult To Position 134 134
Insufficient Information 131 131
Device Issue 130 130
Difficult or Delayed Activation 123 123
Activation, Positioning or Separation Problem 100 100
Material Twisted/Bent 97 97
Device-Device Incompatibility 93 93
Deformation Due to Compressive Stress 92 92
Material Separation 86 86
Inadequacy of Device Shape and/or Size 83 83
Positioning Problem 82 82
Difficult or Delayed Positioning 78 78
Entrapment of Device 77 77
Material Protrusion/Extrusion 77 77
Appropriate Term/Code Not Available 73 73
No Apparent Adverse Event 58 58
Sticking 58 58
Malposition of Device 53 53
Device Dislodged or Dislocated 53 53
Expulsion 52 52
Unintended Movement 40 40
Impedance Problem 39 39
Failure to Disconnect 33 33
Device Operational Issue 30 30
Difficult to Insert 30 30
Material Too Rigid or Stiff 29 29
Unsealed Device Packaging 28 28
Defective Device 25 25
Device Fell 25 25
Component Missing 24 24
Device Damaged by Another Device 22 22
Separation Problem 22 22
Device Markings/Labelling Problem 20 20
Patient-Device Incompatibility 19 19
Improper or Incorrect Procedure or Method 18 18
Use of Device Problem 18 18
Component Falling 18 18
Device Difficult to Setup or Prepare 17 17
Fluid/Blood Leak 15 15
Material Integrity Problem 14 14
Knotted 13 13
Material Frayed 12 12
Contamination 12 12
Device Contamination with Chemical or Other Material 12 12
Delivery System Failure 11 11
Defective Component 10 10
Partial Blockage 10 10
Device Slipped 10 10
Difficult to Open or Remove Packaging Material 10 10
Activation Failure 9 9
Packaging Problem 8 8
Fitting Problem 8 8
Structural Problem 8 8
Contamination /Decontamination Problem 8 8
Crack 7 7
Electrical /Electronic Property Problem 7 7
Difficult to Fold, Unfold or Collapse 6 6
Collapse 6 6
Connection Problem 6 6
Component Misassembled 6 6
Noise, Audible 6 6
Inaccurate Information 5 5
Inadequate User Interface 5 5
Tear, Rip or Hole in Device Packaging 5 5
Air Leak 5 5
Material Fragmentation 5 5
Coiled 4 4
Leak/Splash 4 4
Looping 4 4
Misconnection 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9944 9944
No Clinical Signs, Symptoms or Conditions 3983 3983
No Known Impact Or Consequence To Patient 1420 1420
No Patient Involvement 542 542
Aneurysm 372 372
Headache 147 147
Death 140 140
Stroke/CVA 135 135
Hemorrhage, Subarachnoid 128 128
Thrombus 127 127
Rupture 114 114
Neurological Deficit/Dysfunction 109 109
Thrombosis 105 105
Device Embedded In Tissue or Plaque 92 92
Hemorrhage/Bleeding 85 85
Infarction, Cerebral 71 71
Foreign Body In Patient 66 66
Transient Ischemic Attack 65 65
Weakness 65 65
No Code Available 64 64
Intracranial Hemorrhage 57 57
Ischemia 52 52
Thrombosis/Thrombus 49 49
Visual Disturbances 43 43
Hemorrhage, Cerebral 43 43
Abdominal Pain 41 41
Insufficient Information 39 39
No Information 39 39
Occlusion 37 37
Pain 36 36
Vasoconstriction 36 36
Thromboembolism 36 36
Ischemia Stroke 35 35
Ruptured Aneurysm 34 34
Reaction 34 34
Perforation 34 34
Fever 33 33
Hydrocephalus 30 30
Vomiting 29 29
Nausea 26 26
Hematoma 26 26
Unspecified Infection 25 25
Inflammation 25 25
Abscess 24 24
Paresis 24 24
Patient Problem/Medical Problem 24 24
Dysphasia 23 23
Injury 21 21
Therapeutic Response, Decreased 20 20
Extravasation 20 20
Perforation of Vessels 19 19
Liver Damage/Dysfunction 19 19
High Blood Pressure/ Hypertension 18 18
Obstruction/Occlusion 18 18
Embolism 16 16
Necrosis 16 16
Paralysis 16 16
Numbness 15 15
Vascular System (Circulation), Impaired 14 14
Edema 14 14
Muscle Weakness 12 12
Visual Impairment 12 12
Stenosis 12 12
Ascites 11 11
Test Result 11 11
Vascular Dissection 11 11
Embolism/Embolus 10 10
Nerve Damage 10 10
Cardiac Arrest 10 10
Low Blood Pressure/ Hypotension 9 9
Foreign Body Reaction 9 9
Dizziness 9 9
Blood Loss 9 9
Unspecified Nervous System Problem 8 8
Convulsion/Seizure 8 8
Cancer 8 8
Ulcer 8 8
Loss of consciousness 8 8
Cognitive Changes 8 8
Neuropathy 8 8
Pneumonia 8 8
Sepsis 8 8
Encephalopathy 8 8
Vitreous Floaters 8 8
Embolus 8 8
Vessel Or Plaque, Device Embedded In 7 7
Fistula 7 7
Fatigue 7 7
Seizures 7 7
Lethargy 7 7
Meningitis 7 7
Cerebral Edema 7 7
Swelling/ Edema 7 7
Coma 6 6
Neck Pain 6 6
Loss of Vision 6 6
Tingling 6 6
Swelling 6 6
Hepatitis 6 6
Pulmonary Embolism 5 5

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, dba ev3 Neurovascular III Jan-26-2012
7 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-24-2012
8 Micro Therapeutics, Inc. II Jun-13-2022
9 Microvention, Inc. II Feb-27-2020
10 Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 II Jan-03-2011
11 Penumbra Inc. I Apr-12-2011
12 Stryker Neurovascular II Jul-11-2016
13 Stryker Neurovascular II Apr-19-2016
14 Stryker Neurovascular II Dec-16-2014
15 Stryker Neurovascular II Dec-13-2013
-
-