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TPLC
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Device
device, vascular, for promoting embolization
Product Code
KRD
Regulation Number
870.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABK BIOMEDICAL INC
SUBSTANTIALLY EQUIVALENT
2
ARTIO MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ARTVENTIVE MEDICAL GROUP, INC.
SUBSTANTIALLY EQUIVALENT
1
BAIT USA, LLC
SUBSTANTIALLY EQUIVALENT
1
BIOSPHERE MEDICAL, S.A.
SUBSTANTIALLY EQUIVALENT
3
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
C. R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
EMBOLIC ACCELERATION, LLC
SUBSTANTIALLY EQUIVALENT
1
KA MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEM, INC.
SUBSTANTIALLY EQUIVALENT
1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
1
MICROVENTION INC.
SUBSTANTIALLY EQUIVALENT
2
OBSIDIO, INC.
SUBSTANTIALLY EQUIVALENT
1
OKAMI MEDICAL
SUBSTANTIALLY EQUIVALENT
3
SHAPE MEMORY MEDICAL
SUBSTANTIALLY EQUIVALENT
1
SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1185
1185
2020
1167
1167
2021
1444
1444
2022
1498
1498
2023
1374
1374
2024
281
281
Device Problems
MDRs with this Device Problem
Events in those MDRs
Separation Failure
1509
1509
Detachment of Device or Device Component
1275
1275
Stretched
837
837
Adverse Event Without Identified Device or Use Problem
670
670
Physical Resistance/Sticking
638
638
Failure to Advance
466
466
Break
371
371
Premature Separation
357
357
Entrapment of Device
354
354
Migration
292
292
Difficult to Advance
274
274
Material Deformation
225
225
Premature Activation
185
185
Positioning Problem
181
181
Material Twisted/Bent
172
172
Deformation Due to Compressive Stress
167
167
Difficult to Remove
163
163
Migration or Expulsion of Device
144
144
Unraveled Material
128
128
Material Separation
90
90
Device Difficult to Setup or Prepare
85
85
Off-Label Use
77
77
Device-Device Incompatibility
70
70
Unintended Movement
69
69
Material Integrity Problem
66
66
Patient Device Interaction Problem
62
62
Packaging Problem
53
53
Difficult or Delayed Separation
52
52
Malposition of Device
50
50
Material Protrusion/Extrusion
49
49
Inadequacy of Device Shape and/or Size
45
45
Fracture
42
42
Activation, Positioning or Separation Problem
41
41
Difficult or Delayed Positioning
40
40
Positioning Failure
38
38
Material Rupture
35
35
Difficult to Insert
30
30
Activation Problem
30
30
Product Quality Problem
26
26
Use of Device Problem
26
26
Material Split, Cut or Torn
25
25
Improper or Incorrect Procedure or Method
24
24
Separation Problem
21
21
No Apparent Adverse Event
19
19
Human-Device Interface Problem
18
18
Therapy Delivered to Incorrect Body Area
18
18
Retraction Problem
18
18
Component Missing
17
17
Activation Failure
16
16
Difficult to Fold, Unfold or Collapse
15
15
Device Dislodged or Dislocated
12
12
Contamination
11
11
Display or Visual Feedback Problem
10
10
Device Markings/Labelling Problem
10
10
Incomplete or Missing Packaging
9
9
Obstruction of Flow
9
9
Leak/Splash
9
9
Appropriate Term/Code Not Available
9
9
Device Contaminated During Manufacture or Shipping
9
9
Material Fragmentation
8
8
Unintended Ejection
8
8
Fluid/Blood Leak
8
8
Defective Device
8
8
Device Damaged by Another Device
7
7
Poor Quality Image
7
7
Mechanical Problem
6
6
Crack
5
5
Compatibility Problem
4
4
Biocompatibility
4
4
Contamination /Decontamination Problem
4
4
Tear, Rip or Hole in Device Packaging
4
4
Insufficient Information
4
4
Failure to Disconnect
3
3
Expulsion
3
3
Device Contamination with Chemical or Other Material
3
3
Difficult to Open or Remove Packaging Material
3
3
Nonstandard Device
3
3
Unsealed Device Packaging
3
3
Delivered as Unsterile Product
2
2
Clumping in Device or Device Ingredient
2
2
Electrical /Electronic Property Problem
2
2
Connection Problem
2
2
Patient-Device Incompatibility
2
2
Expiration Date Error
2
2
Peeled/Delaminated
2
2
Therapeutic or Diagnostic Output Failure
2
2
Output Problem
2
2
Failure to Eject
2
2
Component Misassembled
2
2
Material Too Soft/Flexible
1
1
Firing Problem
1
1
Inaccurate Information
1
1
Poor Visibility
1
1
Misassembly by Users
1
1
Defective Component
1
1
Difficult or Delayed Activation
1
1
Component or Accessory Incompatibility
1
1
Material Discolored
1
1
Collapse
1
1
Difficult to Flush
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3866
3866
No Consequences Or Impact To Patient
1078
1079
No Known Impact Or Consequence To Patient
755
755
Aneurysm
245
245
No Code Available
134
134
Foreign Body In Patient
120
120
Insufficient Information
95
95
Thromboembolism
72
72
Hemorrhage/Bleeding
53
53
Pain
51
51
Device Embedded In Tissue or Plaque
50
50
Obstruction/Occlusion
49
49
Stroke/CVA
47
47
Intracranial Hemorrhage
46
46
Thrombosis/Thrombus
45
45
Ruptured Aneurysm
45
45
Ischemia Stroke
39
39
Embolism/Embolus
37
37
Death
37
37
Vasoconstriction
35
35
Infarction, Cerebral
28
28
Hematoma
24
24
Ischemia
23
23
Perforation of Vessels
21
21
No Patient Involvement
20
20
Hypersensitivity/Allergic reaction
19
19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
18
18
Patient Problem/Medical Problem
18
18
Necrosis
18
18
Sepsis
17
17
Abdominal Pain
17
17
Fever
16
16
Therapeutic Response, Decreased
15
15
Pseudoaneurysm
15
15
Low Blood Pressure/ Hypotension
14
14
Convulsion/Seizure
14
14
Rupture
13
13
Unspecified Infection
13
13
Abscess
12
12
Inflammation
12
12
Hydrocephalus
12
12
Foreign Body Embolism
12
12
Stenosis
12
12
Unspecified Tissue Injury
11
11
Cardiac Arrest
11
11
Embolism
11
11
Vomiting
10
10
Swelling/ Edema
10
10
Thrombosis
10
10
Arrhythmia
9
9
Failure of Implant
9
9
Renal Failure
9
9
Pancreatitis
9
9
Hemorrhage, Subarachnoid
9
9
Cardiac Tamponade
9
9
Chest Pain
8
8
Neurological Deficit/Dysfunction
8
8
Muscle Weakness
8
8
Heart Failure/Congestive Heart Failure
8
8
Vascular Dissection
8
8
Fatigue
7
7
Ascites
7
7
Tachycardia
7
7
Endocarditis
7
7
Autoimmune Disorder
7
7
Nerve Damage
7
7
Headache
7
7
High Blood Pressure/ Hypertension
7
7
Encephalopathy
6
6
Perforation
6
6
Liver Damage/Dysfunction
6
6
Myocardial Infarction
6
6
Vascular System (Circulation), Impaired
6
6
Pleural Effusion
6
6
Sleep Dysfunction
6
6
Paresthesia
6
6
Anemia
5
5
Complaint, Ill-Defined
5
5
Hair Loss
5
5
Shock
5
5
Gastrointestinal Hemorrhage
5
5
Pulmonary Edema
5
5
No Information
5
5
Transient Ischemic Attack
5
5
Occlusion
5
5
Cognitive Changes
5
5
Numbness
5
5
Itching Sensation
5
5
Paralysis
5
5
Fistula
5
5
Pneumonia
4
4
Thrombus
4
4
Respiratory Failure
4
4
Hemolysis
4
4
Arthralgia
4
4
Nausea
4
4
Foreign Body Reaction
4
4
Malaise
4
4
Aortic Valve Insufficiency/ Regurgitation
4
4
Chest Tightness/Pressure
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
BALT USA, LLC
II
Feb-08-2024
2
Boston Scientific Corporation
I
Mar-27-2024
3
Cook Incorporated
II
Jun-06-2022
4
MICROVENTION INC.
II
Oct-27-2023
5
Microvention, Inc.
II
Feb-13-2020
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