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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
1. K210562
HRSpheres Narrow-Size Embolic Microspheres
MDR Year
MDR Reports
MDR Events
2019
1185
1185
2020
1167
1167
2021
1444
1444
2022
1498
1498
2023
1374
1374
2024
402
402
Device Problems
MDRs with this Device Problem
Events in those MDRs
Separation Failure
1539
1539
Detachment of Device or Device Component
1287
1287
Stretched
851
851
Adverse Event Without Identified Device or Use Problem
686
686
Physical Resistance/Sticking
662
662
Failure to Advance
475
475
Break
379
379
Premature Separation
372
372
Entrapment of Device
354
354
Migration
294
294
Difficult to Advance
278
278
Material Deformation
235
235
Premature Activation
189
189
Positioning Problem
182
182
Material Twisted/Bent
172
172
Difficult to Remove
169
169
Deformation Due to Compressive Stress
167
167
Migration or Expulsion of Device
144
144
Unraveled Material
131
131
Material Separation
91
91
Device Difficult to Setup or Prepare
86
86
Off-Label Use
79
79
Device-Device Incompatibility
70
70
Unintended Movement
70
70
Material Integrity Problem
68
68
Patient Device Interaction Problem
62
62
Packaging Problem
54
54
Difficult or Delayed Separation
52
52
Material Protrusion/Extrusion
50
50
Malposition of Device
50
50
Inadequacy of Device Shape and/or Size
47
47
Fracture
42
42
Activation, Positioning or Separation Problem
41
41
Difficult or Delayed Positioning
40
40
Positioning Failure
39
39
Material Rupture
35
35
Activation Problem
31
31
Difficult to Insert
30
30
Use of Device Problem
27
27
Product Quality Problem
26
26
Material Split, Cut or Torn
25
25
Improper or Incorrect Procedure or Method
24
24
Separation Problem
22
22
No Apparent Adverse Event
20
20
Therapy Delivered to Incorrect Body Area
19
19
Retraction Problem
18
18
Component Missing
18
18
Human-Device Interface Problem
18
18
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
Device Contaminated During Manufacture or Shipping
10
10
Appropriate Term/Code Not Available
9
9
Incomplete or Missing Packaging
9
9
Obstruction of Flow
9
9
Leak/Splash
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
Insufficient Information
5
5
Compatibility Problem
4
4
Contamination /Decontamination Problem
4
4
Biocompatibility
4
4
Tear, Rip or Hole in Device Packaging
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
Output Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Component Misassembled
2
2
Failure to Eject
2
2
Firing Problem
1
1
Material Too Soft/Flexible
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
Device Tipped Over
1
1
Component or Accessory Incompatibility
1
1
Material Discolored
1
1
Collapse
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3982
3982
No Consequences Or Impact To Patient
1078
1079
No Known Impact Or Consequence To Patient
755
755
Aneurysm
247
247
No Code Available
134
134
Foreign Body In Patient
123
123
Insufficient Information
95
95
Thromboembolism
72
72
Hemorrhage/Bleeding
54
54
Pain
51
51
Device Embedded In Tissue or Plaque
50
50
Obstruction/Occlusion
49
49
Stroke/CVA
47
47
Intracranial Hemorrhage
46
46
Ruptured Aneurysm
45
45
Thrombosis/Thrombus
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
Hypersensitivity/Allergic reaction
20
20
No Patient Involvement
20
20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Patient Problem/Medical Problem
18
18
Necrosis
18
18
Sepsis
18
18
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
Unspecified Infection
13
13
Rupture
13
13
Stenosis
12
12
Inflammation
12
12
Abscess
12
12
Hydrocephalus
12
12
Foreign Body Embolism
12
12
Swelling/ Edema
11
11
Unspecified Tissue Injury
11
11
Cardiac Arrest
11
11
Embolism
11
11
Vomiting
10
10
Thrombosis
10
10
Cardiac Tamponade
9
9
Renal Failure
9
9
Arrhythmia
9
9
Failure of Implant
9
9
High Blood Pressure/ Hypertension
9
9
Hemorrhage, Subarachnoid
9
9
Pancreatitis
9
9
Heart Failure/Congestive Heart Failure
8
8
Vascular Dissection
8
8
Muscle Weakness
8
8
Neurological Deficit/Dysfunction
8
8
Chest Pain
8
8
Tachycardia
8
8
Ascites
7
7
Autoimmune Disorder
7
7
Fatigue
7
7
Endocarditis
7
7
Nerve Damage
7
7
Headache
7
7
Myocardial Infarction
6
6
Liver Damage/Dysfunction
6
6
Encephalopathy
6
6
Sleep Dysfunction
6
6
Vascular System (Circulation), Impaired
6
6
Perforation
6
6
Pleural Effusion
6
6
Paresthesia
6
6
No Information
5
5
Pericardial Effusion
5
5
Gastrointestinal Hemorrhage
5
5
Paralysis
5
5
Pulmonary Edema
5
5
Shock
5
5
Transient Ischemic Attack
5
5
Cognitive Changes
5
5
Complaint, Ill-Defined
5
5
Numbness
5
5
Fistula
5
5
Anemia
5
5
Itching Sensation
5
5
Occlusion
5
5
Hair Loss
5
5
Hemolysis
4
4
Hemothorax
4
4
Nausea
4
4
Foreign Body Reaction
4
4
Arthralgia
4
4
Malaise
4
4
Dysphasia
4
4
Respiratory Failure
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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