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TPLC
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Device
device, neurovascular embolization
Regulation Description
Neurovascular embolization device.
Product Code
HCG
Regulation Number
882.5950
Device Class
2
Premarket Reviews
Manufacturer
Decision
BALT USA, LLC
SUBSTANTIALLY EQUIVALENT
3
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
3
PENUMBRA, INC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
2
STRYKER NEUROVSCULAR
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1753
1753
2021
2267
2267
2022
663
663
2023
569
569
2024
557
557
2025
211
211
Device Problems
MDRs with this Device Problem
Events in those MDRs
Premature Separation
1668
1668
Physical Resistance/Sticking
1642
1642
Failure to Advance
1429
1429
Material Deformation
438
438
Separation Failure
376
376
Fracture
314
314
Adverse Event Without Identified Device or Use Problem
295
295
Detachment of Device or Device Component
283
283
Difficult or Delayed Separation
274
274
Migration
222
222
Mechanical Problem
216
216
Break
143
143
Stretched
138
138
Failure to Fold
111
111
Unraveled Material
89
89
Expulsion
62
62
Difficult to Advance
61
61
Difficult to Remove
38
38
Material Twisted/Bent
28
28
Device Dislodged or Dislocated
25
25
No Apparent Adverse Event
23
23
Component Missing
22
22
Appropriate Term/Code Not Available
18
18
Device-Device Incompatibility
17
17
Positioning Problem
15
15
Migration or Expulsion of Device
14
14
Separation Problem
13
13
Fluid/Blood Leak
13
13
Insufficient Information
12
12
Difficult or Delayed Positioning
12
12
Device Markings/Labelling Problem
10
10
Activation Failure
9
9
Retraction Problem
9
9
Activation, Positioning or Separation Problem
9
9
Premature Activation
9
9
Entrapment of Device
8
8
Unintended Movement
8
8
Inadequacy of Device Shape and/or Size
7
7
Inaccurate Information
6
6
Malposition of Device
5
5
Material Separation
5
5
Poor Visibility
4
4
Device Difficult to Setup or Prepare
4
4
Device Slipped
4
4
Material Frayed
4
4
Component Misassembled
3
3
No Visual Prompts/Feedback
3
3
Material Split, Cut or Torn
3
3
Corroded
3
3
Deformation Due to Compressive Stress
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4479
4479
No Consequences Or Impact To Patient
1844
1844
Foreign Body In Patient
67
67
Thrombosis/Thrombus
63
63
Aneurysm
52
52
Ruptured Aneurysm
44
44
Insufficient Information
43
43
Ischemia Stroke
43
43
Stroke/CVA
32
32
Hemorrhage/Bleeding
29
29
Intracranial Hemorrhage
28
28
No Known Impact Or Consequence To Patient
21
21
Obstruction/Occlusion
21
21
Rupture
20
20
Muscle Weakness
19
19
Device Embedded In Tissue or Plaque
18
18
Headache
17
17
Hydrocephalus
15
15
Thromboembolism
15
15
Vasoconstriction
15
15
Stenosis
13
13
Paresis
12
12
Paralysis
12
12
Embolism/Embolus
12
12
Hematoma
11
11
Ischemia
10
10
Visual Impairment
9
9
Cerebral Edema
9
9
Swelling/ Edema
8
8
Perforation of Vessels
8
8
Inflammation
8
8
Convulsion/Seizure
8
8
Unspecified Nervous System Problem
8
8
Perforation
7
7
Speech Disorder
7
7
Cognitive Changes
7
7
Failure of Implant
6
6
Loss of Vision
6
6
Hemorrhagic Stroke
6
6
Dysphasia
6
6
Extravasation
6
6
Visual Disturbances
6
6
Vascular Dissection
5
5
Unspecified Infection
5
5
Neuropathy
5
5
Thrombosis
5
5
Transient Ischemic Attack
5
5
Coma
4
4
Cardiac Arrest
4
4
Foreign Body Reaction
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
BALT USA, LLC
II
Jun-18-2025
2
BALT USA, LLC
II
Feb-08-2024
3
BALT USA, LLC
II
Oct-20-2022
4
BALT USA, LLC
II
Sep-06-2022
5
BALT USA, LLC
II
Feb-22-2022
6
Micro Therapeutics, Inc.
II
Jun-13-2022
7
Microvention, Inc.
II
Feb-27-2020
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