Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
catheter, intravascular occluding, temporary
Regulation Description
Vascular clamp.
Product Code
MJN
Regulation Number
870.4450
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABIOMED INC.
SE - WITH LIMITATIONS
1
ARCH CATHETER, LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
FRONT LINE MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
NEURESCUE APS
SUBSTANTIALLY EQUIVALENT
1
PRYTIME MEDICAL DEVICES, INC
SUBSTANTIALLY EQUIVALENT
1
PRYTIME MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
RENALPRO MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
RENOVORX, INC.
SUBSTANTIALLY EQUIVALENT
1
SPECTRANETICS, INC.
SUBSTANTIALLY EQUIVALENT
1
ZIEN MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
157
157
2021
158
158
2022
148
148
2023
181
181
2024
225
225
2025
69
69
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
188
188
Inflation Problem
103
103
Adverse Event Without Identified Device or Use Problem
98
98
Deflation Problem
78
78
Leak/Splash
78
78
Fluid/Blood Leak
76
76
Failure to Deflate
50
50
Burst Container or Vessel
47
47
Material Puncture/Hole
46
46
Break
37
37
Entrapment of Device
28
28
Patient Device Interaction Problem
27
27
Difficult to Remove
17
17
Material Deformation
13
13
Difficult to Open or Close
11
11
Fracture
10
10
Improper or Incorrect Procedure or Method
8
8
Physical Resistance/Sticking
8
8
Mechanical Problem
7
7
Gas/Air Leak
6
6
Difficult to Advance
6
6
Failure to Advance
6
6
Detachment of Device or Device Component
5
5
Positioning Failure
5
5
Obstruction of Flow
5
5
Contamination
5
5
Unintended Movement
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Defective Component
4
4
Insufficient Information
3
3
Device Dislodged or Dislocated
3
3
Unintended Deflation
3
3
Difficult to Insert
3
3
Failure to Unfold or Unwrap
3
3
Off-Label Use
3
3
Material Twisted/Bent
3
3
Use of Device Problem
3
3
Flaked
3
3
Appropriate Term/Code Not Available
2
2
No Apparent Adverse Event
2
2
Material Split, Cut or Torn
2
2
Failure to Eject
2
2
Device Damaged by Another Device
2
2
Air/Gas in Device
2
2
Positioning Problem
2
2
Material Integrity Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Degraded
2
2
Improper Flow or Infusion
1
1
Human-Device Interface Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
624
624
No Known Impact Or Consequence To Patient
47
47
Vascular Dissection
38
38
No Consequences Or Impact To Patient
36
36
Insufficient Information
25
25
Perforation of Vessels
22
22
Intracranial Hemorrhage
21
21
Rupture
20
20
Thrombosis/Thrombus
19
19
Hemorrhage/Bleeding
19
19
Thrombus
15
15
Obstruction/Occlusion
13
13
Ruptured Aneurysm
10
10
Unspecified Nervous System Problem
9
9
Ischemia
9
9
Thromboembolism
8
8
Embolism/Embolus
7
7
Foreign Body In Patient
7
7
No Patient Involvement
7
7
Paresis
7
7
Ischemia Stroke
6
6
Hematoma
6
6
Stroke/CVA
6
6
Aneurysm
5
5
Fistula
4
4
Death
4
4
Vasoconstriction
4
4
Pulmonary Embolism
4
4
Foreign Body Embolism
3
3
Hemorrhagic Stroke
3
3
Hydrocephalus
3
3
Nervous System Injury
3
3
Dysphasia
3
3
Cognitive Changes
3
3
Neurological Deficit/Dysfunction
3
3
Muscle Weakness
3
3
Laceration(s)
3
3
Unintended Radiation Exposure
2
2
Swelling/ Edema
2
2
Great Vessel Perforation
2
2
Loss of Vision
2
2
Neurogenic Shock
2
2
Blurred Vision
2
2
Transient Ischemic Attack
2
2
Iatrogenic Source
2
2
Septic Shock
2
2
Extravasation
2
2
Foreign Body Reaction
2
2
Headache
2
2
Status Epilepticus
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Prytime Medical Devices, Inc.
II
Dec-23-2020
2
Spectranetics Corporation
II
Jun-01-2020
3
W. L. Gore & Associates Inc.
II
Aug-25-2021
-
-