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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
41
41
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
1615
1615
Premature Separation
1571
1571
Failure to Advance
1429
1429
Material Deformation
434
434
Separation Failure
375
375
Fracture
288
288
Adverse Event Without Identified Device or Use Problem
285
285
Detachment of Device or Device Component
279
279
Difficult or Delayed Separation
270
270
Mechanical Problem
216
216
Migration
199
199
Break
142
142
Stretched
131
131
Failure to Fold
108
108
Unraveled Material
85
85
Expulsion
61
61
Difficult to Advance
61
61
Difficult to Remove
38
38
Material Twisted/Bent
28
28
Device Dislodged or Dislocated
23
23
No Apparent Adverse Event
22
22
Component Missing
21
21
Appropriate Term/Code Not Available
18
18
Device-Device Incompatibility
17
17
Positioning Problem
15
15
Migration or Expulsion of Device
13
13
Fluid/Blood Leak
13
13
Difficult or Delayed Positioning
12
12
Insufficient Information
12
12
Separation Problem
12
12
Device Markings/Labelling Problem
10
10
Premature Activation
9
9
Activation Failure
9
9
Activation, Positioning or Separation Problem
9
9
Retraction Problem
9
9
Unintended Movement
8
8
Entrapment of Device
7
7
Inadequacy of Device Shape and/or Size
7
7
Inaccurate Information
6
6
Malposition of Device
5
5
Material Separation
5
5
Device Slipped
4
4
Material Frayed
4
4
Device Difficult to Setup or Prepare
4
4
Poor Visibility
4
4
Corroded
3
3
Deformation Due to Compressive Stress
3
3
Component Misassembled
3
3
Material Split, Cut or Torn
3
3
Unsealed Device Packaging
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4337
4337
No Consequences Or Impact To Patient
1844
1844
Foreign Body In Patient
64
64
Thrombosis/Thrombus
62
62
Aneurysm
50
50
Ruptured Aneurysm
42
42
Ischemia Stroke
41
41
Insufficient Information
39
39
Stroke/CVA
29
29
Hemorrhage/Bleeding
28
28
Intracranial Hemorrhage
26
26
No Known Impact Or Consequence To Patient
21
21
Rupture
20
20
Obstruction/Occlusion
18
18
Headache
17
17
Muscle Weakness
16
16
Thromboembolism
15
15
Hydrocephalus
15
15
Vasoconstriction
14
14
Paresis
12
12
Embolism/Embolus
12
12
Paralysis
11
11
Stenosis
11
11
Hematoma
11
11
Device Embedded In Tissue or Plaque
10
10
Ischemia
10
10
Cerebral Edema
9
9
Visual Impairment
9
9
Swelling/ Edema
8
8
Convulsion/Seizure
8
8
Perforation of Vessels
8
8
Inflammation
8
8
Unspecified Nervous System Problem
8
8
Perforation
7
7
Cognitive Changes
7
7
Extravasation
6
6
Loss of Vision
6
6
Visual Disturbances
6
6
Dysphasia
6
6
Hemorrhagic Stroke
6
6
Neuropathy
5
5
Thrombosis
5
5
Speech Disorder
5
5
Unspecified Infection
5
5
Failure of Implant
5
5
Coma
4
4
Foreign Body Reaction
4
4
Fever
4
4
Death
4
4
Cardiac Arrest
4
4
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
Micro Therapeutics, Inc.
II
Jun-13-2022
6
Microvention, Inc.
II
Feb-27-2020
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