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TPLC
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Device
catheter, embolectomy
Regulation Description
Embolectomy catheter.
Product Code
DXE
Regulation Number
870.5150
Device Class
2
Premarket Reviews
Manufacturer
Decision
APPLIED MEDICAL RESOURCES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES
SUBSTANTIALLY EQUIVALENT
3
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
3
MIVI NEUROVASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
547
547
2021
333
333
2022
463
463
2023
436
436
2024
378
378
2025
136
136
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
482
482
Material Fragmentation
344
344
Break
250
250
Adverse Event Without Identified Device or Use Problem
215
215
Material Deformation
159
159
Detachment of Device or Device Component
129
129
Leak/Splash
117
117
Suction Problem
105
105
Display or Visual Feedback Problem
104
104
Deflation Problem
100
100
Physical Resistance/Sticking
94
94
Material Separation
62
62
Failure to Deflate
53
53
Burst Container or Vessel
47
47
Inflation Problem
41
41
Device Difficult to Setup or Prepare
38
38
Entrapment of Device
35
35
Material Puncture/Hole
34
34
Material Disintegration
31
31
Failure to Advance
31
31
Degraded
29
29
Difficult to Remove
26
26
Pumping Problem
21
21
Defective Device
19
19
Mechanical Problem
14
14
Material Split, Cut or Torn
14
14
Stretched
14
14
Appropriate Term/Code Not Available
12
12
Material Twisted/Bent
12
12
Difficult to Advance
11
11
Material Integrity Problem
11
11
Suction Failure
10
10
Fluid/Blood Leak
10
10
Material Perforation
8
8
Fracture
6
6
Device Damaged Prior to Use
5
5
Device Displays Incorrect Message
5
5
Deformation Due to Compressive Stress
5
5
Separation Problem
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Difficult to Insert
5
5
Crack
4
4
Device Contamination with Chemical or Other Material
4
4
Failure to Prime
4
4
Mechanical Jam
4
4
Unraveled Material
4
4
Migration
3
3
Device Dislodged or Dislocated
3
3
Nonstandard Device
3
3
Decrease in Suction
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1604
1604
No Consequences Or Impact To Patient
359
359
No Known Impact Or Consequence To Patient
84
84
Insufficient Information
55
55
Foreign Body In Patient
52
52
Device Embedded In Tissue or Plaque
30
30
No Patient Involvement
23
23
Stroke/CVA
19
19
Low Blood Pressure/ Hypotension
17
17
Vascular Dissection
16
16
Cardiac Tamponade
16
16
Hemorrhage/Bleeding
15
15
Embolism/Embolus
15
15
Thrombosis/Thrombus
14
14
Death
12
12
Intracranial Hemorrhage
12
12
Myocardial Infarction
9
9
Hemorrhage, Cerebral
9
9
Perforation of Vessels
8
8
Bradycardia
7
7
Foreign Body Embolism
7
7
Pericardial Effusion
7
7
Vasoconstriction
7
7
Hematoma
7
7
Perforation
6
6
Obstruction/Occlusion
6
6
Hemorrhage, Subarachnoid
6
6
Ischemia
5
5
Pulmonary Embolism
5
5
Pain
5
5
No Code Available
5
5
Cardiac Perforation
5
5
Thromboembolism
5
5
Stenosis
4
4
Infarction, Cerebral
4
4
Renal Failure
4
4
Heart Failure/Congestive Heart Failure
4
4
Laceration(s)
4
4
Rupture
4
4
Thrombus
4
4
Thrombosis
3
3
Failure of Implant
3
3
Pseudoaneurysm
3
3
Unspecified Infection
3
3
Injury
3
3
Transient Ischemic Attack
3
3
Cardiac Arrest
3
3
Tricuspid Valve Insufficiency/ Regurgitation
3
3
Edema
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Applied Medical Resources Corp
I
May-07-2020
2
Arrow International Inc
I
Nov-18-2021
3
Edwards Lifesciences, LLC
II
Nov-06-2023
4
Edwards Lifesciences, LLC
II
Oct-28-2022
5
INARI MEDICAL
II
Jun-09-2020
6
LeMaitre Vascular, Inc.
II
May-12-2025
7
LeMaitre Vascular, Inc.
II
May-15-2024
8
LeMaitre Vascular, Inc.
II
Nov-11-2022
9
LeMaitre Vascular, Inc.
I
Apr-01-2020
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