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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
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 4
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 3
MICROVENTION, INC
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 15
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 10
SPARTAN MICRO, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 9
STRYKER NEUROVSCULAR
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1598 1598
2016 1991 1991
2017 2494 2494
2018 2058 2058
2019 1763 1763
2020 1753 1753
2021 2267 2267
2022 663 663
2023 569 569
2024 557 557
2025 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 3948 3948
Physical Resistance/Sticking 2543 2543
Premature Separation 2033 2033
Physical Resistance 1699 1699
Detachment Of Device Component 1143 1143
Adverse Event Without Identified Device or Use Problem 1102 1102
Separation Failure 823 823
Break 735 735
Stretched 707 707
Material Deformation 699 699
Detachment of Device or Device Component 567 567
Kinked 526 526
Mechanical Problem 511 511
Premature Activation 494 494
Positioning Failure 407 407
Fracture 382 382
Difficult to Advance 354 354
Difficult or Delayed Separation 333 333
Device Operates Differently Than Expected 326 326
Mechanical Jam 315 315
Device Handling Problem 294 294
Migration or Expulsion of Device 269 269
Migration 263 263
Device Damaged Prior to Use 254 254
Unraveled Material 209 209
Failure to Fold 205 205
Bent 188 188
Retraction Problem 172 172
Difficult to Remove 156 156
Out-Of-Box Failure 145 145
Difficult or Delayed Activation 123 123
Device Issue 122 122
Difficult To Position 118 118
Material Twisted/Bent 94 94
Insufficient Information 87 87
Device-Device Incompatibility 84 84
Activation, Positioning or Separation Problem 79 79
Inadequacy of Device Shape and/or Size 78 78
Material Protrusion/Extrusion 71 71
Difficult or Delayed Positioning 70 70
Appropriate Term/Code Not Available 68 68
Material Separation 67 67
Deformation Due to Compressive Stress 65 65
Entrapment of Device 62 62
Expulsion 62 62
Positioning Problem 60 60
Device Dislodged or Dislocated 51 51
Malposition of Device 42 42
Unintended Movement 40 40
No Apparent Adverse Event 31 31

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9085 9085
No Clinical Signs, Symptoms or Conditions 4406 4406
No Known Impact Or Consequence To Patient 890 890
No Patient Involvement 526 526
Aneurysm 332 332
Headache 140 140
Thrombus 120 120
Hemorrhage, Subarachnoid 119 119
Stroke/CVA 116 116
Neurological Deficit/Dysfunction 101 101
Rupture 100 100
Death 97 97
Thrombosis 93 93
Foreign Body In Patient 82 82
Hemorrhage/Bleeding 76 76
Device Embedded In Tissue or Plaque 71 71
Thrombosis/Thrombus 63 63
Ischemia 57 57
Intracranial Hemorrhage 56 56
Weakness 56 56
Infarction, Cerebral 53 53
Transient Ischemic Attack 50 50
No Code Available 48 48
Ruptured Aneurysm 43 43
Ischemia Stroke 43 43
Insufficient Information 42 42
Visual Disturbances 41 41
Abdominal Pain 38 38
Hemorrhage, Cerebral 37 37
Vasoconstriction 32 32
Hydrocephalus 32 32
Pain 31 31
Occlusion 30 30
Reaction 29 29
Fever 28 28
Paresis 27 27
Nausea 26 26
Vomiting 26 26
Thromboembolism 25 25
Hematoma 25 25
Unspecified Infection 24 24
Patient Problem/Medical Problem 24 24
Inflammation 24 24
Obstruction/Occlusion 23 23
Dysphasia 22 22
No Information 22 22
Perforation 21 21
Abscess 21 21
Therapeutic Response, Decreased 20 20
Muscle Weakness 19 19

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
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