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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
1
CODMAN & SHURTLEFF, INC.
SUBSTANTIALLY EQUIVALENT
2
JOHNSON & JOHNSON PROFESSIONALS, INC.
SUBSTANTIALLY EQUIVALENT
1
KANEKA CORP.
SUBSTANTIALLY EQUIVALENT
1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
1
MICROVENTION, INC.
SUBSTANTIALLY EQUIVALENT
3
PENUMBRA, INC.
SUBSTANTIALLY EQUIVALENT
4
STRYKER NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2016
1990
1990
2017
2494
2494
2018
2058
2058
2019
1763
1763
2020
1753
1753
2021
543
543
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Advance
3110
3110
Physical Resistance/Sticking
1709
1709
Physical Resistance
1538
1538
Detachment Of Device Component
975
975
Premature Separation
786
786
Adverse Event Without Identified Device or Use Problem
724
724
Separation Failure
560
560
Break
546
546
Material Deformation
473
473
Stretched
460
460
Mechanical Problem
398
398
Kinked
382
382
Detachment of Device or Device Component
367
367
Premature Activation
347
347
Mechanical Jam
310
310
Device Handling Problem
285
285
Positioning Failure
275
275
Device Operates Differently Than Expected
274
274
Device Damaged Prior to Use
239
239
Difficult to Advance
194
194
Migration or Expulsion of Device
188
188
Bent
165
165
Difficult or Delayed Separation
152
152
Failure to Fold
145
145
Retraction Problem
137
137
Out-Of-Box Failure
130
130
Unraveled Material
122
122
Difficult or Delayed Activation
120
120
Fracture
113
113
Difficult to Remove
112
112
Device Issue
104
104
Difficult To Position
93
93
Migration
93
93
Material Twisted/Bent
86
86
Device-Device Incompatibility
72
72
Inadequacy of Device Shape and/or Size
61
61
Material Protrusion/Extrusion
59
59
Activation, Positioning or SeparationProblem
56
56
Deformation Due to Compressive Stress
53
53
Difficult or Delayed Positioning
51
51
Material Separation
44
44
Appropriate Term/Code Not Available
38
38
Entrapment of Device
37
37
Positioning Problem
35
35
Unintended Movement
35
35
Device Dislodged or Dislocated
28
28
Insufficient Information
28
28
Device Fell
25
25
Malposition of Device
25
25
Defective Device
24
24
Material Too Rigid or Stiff
22
22
Separation Problem
18
18
Patient-Device Incompatibility
17
17
Device Markings/Labelling Problem
16
16
Expulsion
14
14
Use of Device Problem
14
14
Fluid Leak
14
14
Device Difficult to Setup or Prepare
12
12
Device Operational Issue
12
12
Device Damaged by Another Device
11
11
Material Integrity Problem
11
11
Difficult to Insert
10
10
No Apparent Adverse Event
10
10
Material Frayed
9
9
Knotted
7
7
Sticking
7
7
Device Slipped
7
7
Collapse
6
6
Air Leak
5
5
Component Missing
5
5
Structural Problem
5
5
Contamination
5
5
Device Contamination with Chemical or Other Material
5
5
Defective Component
4
4
Component Misassembled
4
4
Improper or Incorrect Procedure or Method
4
4
Component Falling
4
4
Noise, Audible
4
4
Inadequate User Interface
4
4
Unsealed Device Packaging
4
4
Unintended Ejection
3
3
Crack
3
3
Looping
3
3
Off-Label Use
3
3
Human Factors Issue
3
3
Material Split, Cut or Torn
3
3
Activation Problem
3
3
Physical Property Issue
3
3
Folded
3
3
Difficult to Open or Remove Packaging Material
3
3
Leak/Splash
3
3
Tear, Rip or Hole in Device Packaging
3
3
Failure to Disconnect
3
3
Contamination /Decontamination Problem
3
3
Chemical Problem
2
2
Material Distortion
2
2
Electrical /Electronic Property Problem
2
2
Accessory Incompatible
2
2
Misconnection
2
2
Peeled/Delaminated
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
8308
8308
No Clinical Signs, Symptoms or Conditions
1145
1145
No Patient Involvement
474
474
No Known Impact Or Consequence To Patient
386
386
Aneurysm
260
260
Headache
122
122
Thrombus
109
109
Hemorrhage, Subarachnoid
101
101
Neurological Deficit/Dysfunction
80
80
Thrombosis
74
74
Stroke/CVA
67
67
Death
63
63
Rupture
58
58
Weakness
55
55
Device Embedded In Tissue or Plaque
55
55
Transient Ischemic Attack
43
43
Ischemia
43
43
Hemorrhage/Bleeding
36
36
Visual Disturbances
35
35
Hemorrhage, Cerebral
32
32
Infarction, Cerebral
32
32
No Code Available
30
30
Intracranial Hemorrhage
26
26
Reaction
25
25
Patient Problem/Medical Problem
24
24
Occlusion
20
20
Vomiting
19
19
Foreign Body In Patient
18
18
No Information
17
17
Nausea
17
17
Vasoconstriction
17
17
Perforation
16
16
Unspecified Infection
16
16
Dysphasia
14
14
Hydrocephalus
14
14
Fever
14
14
Abdominal Pain
13
13
Pain
12
12
Injury
12
12
Thromboembolism
12
12
Hematoma
12
12
Perforation of Vessels
12
12
Inflammation
11
11
High Blood Pressure/ Hypertension
10
10
Paresis
10
10
Embolism
10
10
Necrosis
9
9
Extravasation
9
9
Vitreous Floaters
8
8
Blood Loss
8
8
Dizziness
7
7
Embolus
7
7
Thrombosis/Thrombus
7
7
Lethargy
6
6
Abscess
6
6
Edema
6
6
Liver Damage/Dysfunction
6
6
Vascular System (Circulation), Impaired
6
6
Ascites
6
6
Ruptured Aneurysm
6
6
Foreign Body Reaction
5
5
Insufficient Information
5
5
Neck Pain
5
5
Numbness
4
4
Ulcer
4
4
Vessel Or Plaque, Device Embedded In
4
4
Encephalopathy
4
4
Neuropathy
4
4
Pneumonia
4
4
Stenosis
4
4
Therapeutic Response, Decreased
3
3
Seizures
3
3
Obstruction/Occlusion
3
3
Fistula
3
3
Chest Pain
3
3
Bacterial Infection
3
3
Low Blood Pressure/ Hypotension
3
3
Fatigue
3
3
Pulmonary Embolism
3
3
Toxicity
3
3
Cancer
3
3
Rash
2
2
Sepsis
2
2
Septic Shock
2
2
Swelling
2
2
Pulmonary Emphysema
2
2
Gangrene
2
2
Hepatitis
2
2
Biliary Cirrhosis
2
2
Cardiac Arrest
2
2
Diarrhea
2
2
Purulent Discharge
2
2
Disseminated Intravascular Coagulation (DIC)
2
2
Facial Nerve Paralysis
2
2
Hair Loss
2
2
Respiratory Distress
2
2
Paralysis
2
2
Ptosis
2
2
Visual Impairment
2
2
Brain Injury
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Codman & Shurtleff Inc
II
Aug-15-2019
2
Microvention, Inc.
II
Feb-27-2020
3
Stryker Neurovascular
II
Jul-11-2016
4
Stryker Neurovascular
II
Apr-19-2016
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