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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
catheter, embolectomy
Product Code
DXE
Regulation Number
870.5150
Device Class
2
Premarket Reviews
Manufacturer
Decision
APPLIED MEDICAL RESOURCES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
EDWARDS LIFESCIENCES
SUBSTANTIALLY EQUIVALENT
3
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
3
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
1
MIVI NEUROVASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
266
266
2016
795
795
2017
770
770
2018
615
615
2019
594
594
2020
547
547
2021
333
333
2022
463
463
2023
436
436
2024
262
262
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
692
692
Material Rupture
502
502
Aspiration Issue
488
488
Device Displays Incorrect Message
455
455
Material Deformation
452
452
Adverse Event Without Identified Device or Use Problem
410
410
Material Fragmentation
360
360
Kinked
230
230
Material Separation
229
229
Physical Resistance/Sticking
219
219
Deflation Problem
207
207
Detachment of Device or Device Component
189
189
Device Damaged Prior to Use
175
175
Leak/Splash
163
163
Suction Problem
140
140
Physical Resistance
126
126
Failure to Advance
124
124
Display or Visual Feedback Problem
110
110
Entrapment of Device
106
106
Detachment Of Device Component
85
85
Out-Of-Box Failure
75
75
Fracture
73
73
Device Operates Differently Than Expected
71
71
Device Handling Problem
70
70
Burst Container or Vessel
66
66
Failure to Prime
63
63
Material Puncture/Hole
56
56
Difficult to Remove
56
56
Stretched
54
54
Inflation Problem
54
54
Collapse
53
53
Device Difficult to Setup or Prepare
45
45
Failure to Deflate
43
43
Fluid/Blood Leak
43
43
Material Twisted/Bent
39
39
Deformation Due to Compressive Stress
37
37
Difficult to Advance
35
35
Material Disintegration
32
32
Bent
32
32
Hole In Material
27
27
Defective Device
27
27
Material Integrity Problem
26
26
Device Dislodged or Dislocated
25
25
Unraveled Material
25
25
Material Perforation
22
22
Pumping Problem
21
21
Difficult to Insert
21
21
Crack
20
20
Mechanical Problem
18
18
Appropriate Term/Code Not Available
17
17
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
2383
2383
No Clinical Signs, Symptoms or Conditions
1371
1371
No Known Impact Or Consequence To Patient
428
428
No Patient Involvement
343
343
Device Embedded In Tissue or Plaque
132
132
Foreign Body In Patient
79
80
Death
77
77
Insufficient Information
53
53
Stroke/CVA
45
45
No Information
45
45
Low Blood Pressure/ Hypotension
35
35
No Code Available
32
33
Myocardial Infarction
30
30
Renal Failure
28
28
Hemorrhage/Bleeding
27
27
Vascular Dissection
26
26
Intracranial Hemorrhage
23
24
Embolism
23
23
Bradycardia
22
22
Thrombus
21
21
Cardiac Tamponade
20
20
Patient Problem/Medical Problem
19
19
Hemoptysis
16
16
Pulmonary Embolism
16
16
Infarction, Cerebral
14
15
Hemorrhage, Subarachnoid
14
14
Hemorrhage, Cerebral
14
14
Perforation
14
14
Pain
13
13
Blood Loss
13
13
Embolism/Embolus
13
13
Hemolysis
12
12
Stenosis
12
12
Injury
12
12
Cardiac Arrest
11
11
Perforation of Vessels
11
11
Thrombosis/Thrombus
11
11
Hematoma
11
11
Transient Ischemic Attack
10
10
Tachycardia
9
9
Thromboembolism
9
9
Chest Pain
9
9
Pericardial Effusion
8
8
Cardiopulmonary Arrest
8
8
Heart Failure
8
8
Vasoconstriction
8
8
Ischemia
8
8
Occlusion
8
8
Vessel Or Plaque, Device Embedded In
8
8
Obstruction/Occlusion
7
7
Recalls
Manufacturer
Recall Class
Date Posted
1
Applied Medical Resources Corp
I
May-07-2020
2
Arrow International Inc
I
Nov-18-2021
3
Arrow International Inc
II
Sep-30-2016
4
Boston Scientific Corporation
I
Apr-18-2016
5
Boston Scientific Corporation
II
Aug-13-2015
6
Edwards Lifesciences, LLC
II
Nov-06-2023
7
Edwards Lifesciences, LLC
II
Oct-28-2022
8
Edwards Lifesciences, LLC
II
Aug-26-2017
9
INARI MEDICAL
II
Jun-09-2020
10
LeMaitre Vascular, Inc.
II
May-15-2024
11
LeMaitre Vascular, Inc.
II
Nov-11-2022
12
LeMaitre Vascular, Inc.
I
Apr-01-2020
13
LeMaitre Vascular, Inc.
II
Dec-04-2015
-
-