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TPLC
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Device
device, neurovascular embolization
Product Code
HCG
Regulation Number
882.5950
Device Class
2
Premarket Reviews
Manufacturer
Decision
BALT USA, LLC
SUBSTANTIALLY EQUIVALENT
2
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
2
PENUMBRA, INC.
SUBSTANTIALLY EQUIVALENT
2
STRYKER NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
2
STRYKER NEUROVSCULAR
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1763
1763
2020
1753
1753
2021
2267
2267
2022
663
663
2023
569
569
2024
387
387
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
2188
2188
Failure to Advance
1966
1966
Premature Separation
1756
1756
Material Deformation
587
587
Separation Failure
485
485
Detachment of Device or Device Component
407
407
Adverse Event Without Identified Device or Use Problem
313
313
Difficult or Delayed Separation
308
308
Mechanical Problem
302
302
Fracture
277
277
Break
237
237
Migration
213
213
Stretched
193
193
Failure to Fold
145
145
Unraveled Material
98
98
Difficult to Advance
69
69
Material Twisted/Bent
64
64
Difficult to Remove
58
58
Device Damaged Prior to Use
54
54
Expulsion
53
53
Device-Device Incompatibility
34
34
Device Dislodged or Dislocated
30
30
Difficult or Delayed Positioning
26
26
Appropriate Term/Code Not Available
24
24
No Apparent Adverse Event
24
24
Component Missing
22
22
Migration or Expulsion of Device
22
22
Positioning Problem
20
20
Retraction Problem
19
19
Separation Problem
19
19
Device Fell
15
15
Fluid/Blood Leak
13
13
Device Markings/Labelling Problem
12
12
Insufficient Information
12
12
Premature Activation
11
11
Unintended Movement
11
11
Activation, Positioning or Separation Problem
10
10
Entrapment of Device
9
9
Activation Failure
9
9
Material Separation
8
8
Inadequacy of Device Shape and/or Size
8
8
Device Handling Problem
6
6
Malposition of Device
6
6
Material Protrusion/Extrusion
6
6
Inaccurate Information
6
6
Material Frayed
5
5
Component Misassembled
5
5
Poor Visibility
4
4
Device Difficult to Setup or Prepare
4
4
Material Split, Cut or Torn
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4167
4167
No Consequences Or Impact To Patient
3359
3359
No Known Impact Or Consequence To Patient
102
102
No Patient Involvement
82
82
Aneurysm
61
61
Thrombosis/Thrombus
54
54
Foreign Body In Patient
53
53
Ruptured Aneurysm
41
41
Ischemia Stroke
40
40
Insufficient Information
38
38
Intracranial Hemorrhage
32
32
Stroke/CVA
28
28
Rupture
26
26
Hemorrhage/Bleeding
24
24
Device Embedded In Tissue or Plaque
20
20
Headache
19
19
Thromboembolism
17
17
Obstruction/Occlusion
17
17
Vasoconstriction
15
15
Muscle Weakness
14
14
Hydrocephalus
14
14
Unspecified Infection
13
13
Paresis
13
13
Stenosis
11
11
Embolism/Embolus
11
11
Hematoma
11
11
Thrombosis
11
11
Perforation
10
10
Paralysis
9
9
Visual Impairment
9
9
Thrombus
9
9
Death
9
9
Perforation of Vessels
9
9
Convulsion/Seizure
8
8
Fever
8
8
Ischemia
8
8
Cerebral Edema
8
8
Unspecified Nervous System Problem
8
8
Inflammation
7
7
Swelling/ Edema
7
7
Cognitive Changes
7
7
Dysphasia
7
7
Injury
6
6
Extravasation
6
6
High Blood Pressure/ Hypertension
6
6
Cardiac Arrest
6
6
Visual Disturbances
5
5
Patient Problem/Medical Problem
5
5
Loss of Vision
5
5
Neuropathy
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.
II
Jun-13-2022
7
Microvention, Inc.
II
Feb-27-2020
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