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TPLC
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show TPLC since
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2024
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Device
catheter, peripheral, atherectomy
Product Code
MCW
Regulation Number
870.4875
Device Class
2
Premarket Reviews
Manufacturer
Decision
AVINGER, INC.
SUBSTANTIALLY EQUIVALENT
3
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIO FLOW INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIO FLOW, INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIOVASCUALR SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIOVASCULAR SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
4
EXIMO MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
4
EXIMO MEDICAL, LTD.
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC, INC
SUBSTANTIALLY EQUIVALENT
1
REX MEDICAL, L.P.
SUBSTANTIALLY EQUIVALENT
2
SPECTRANETICS INC.
SUBSTANTIALLY EQUIVALENT
1
VOLCANO ATHEROMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
618
618
2020
631
753
2021
734
2930
2022
566
566
2023
575
575
2024
485
485
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
645
889
Break
637
1247
Adverse Event Without Identified Device or Use Problem
551
1527
Entrapment of Device
537
537
Material Separation
295
295
Material Deformation
265
387
Difficult to Remove
228
228
Physical Resistance/Sticking
228
228
Mechanical Problem
204
204
Mechanical Jam
194
194
Suction Problem
158
158
Fracture
114
114
Difficult to Advance
92
92
Device Damaged by Another Device
86
86
Noise, Audible
80
80
Leak/Splash
66
66
Use of Device Problem
63
63
Retraction Problem
51
51
Failure to Advance
47
47
Positioning Problem
40
40
Unexpected Shutdown
34
34
Device Markings/Labelling Problem
28
28
Defective Device
26
26
Device-Device Incompatibility
25
25
Material Split, Cut or Torn
25
25
Material Integrity Problem
24
24
Fluid/Blood Leak
24
24
Deformation Due to Compressive Stress
21
21
Infusion or Flow Problem
20
20
Overheating of Device
20
20
Off-Label Use
17
17
Stretched
16
16
Peeled/Delaminated
16
16
Intermittent Loss of Power
16
16
Device Difficult to Setup or Prepare
14
14
Improper or Incorrect Procedure or Method
14
14
Melted
14
14
Material Puncture/Hole
14
14
Material Twisted/Bent
13
13
No Apparent Adverse Event
12
12
Activation Problem
11
11
Display or Visual Feedback Problem
11
11
Unintended System Motion
11
11
Difficult or Delayed Activation
11
11
Device Contamination with Chemical or Other Material
10
10
Failure to Prime
9
9
Device Displays Incorrect Message
9
9
Insufficient Information
9
9
Output Problem
8
8
Missing Information
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1639
2249
No Consequences Or Impact To Patient
623
623
Foreign Body In Patient
240
240
Vascular Dissection
201
567
Embolism/Embolus
169
413
Perforation of Vessels
149
271
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
123
123
No Known Impact Or Consequence To Patient
123
245
Device Embedded In Tissue or Plaque
114
114
Insufficient Information
76
76
Perforation
76
76
Embolism
58
180
Unintended Radiation Exposure
54
908
Thrombosis/Thrombus
50
50
Pain
36
36
Radiation Exposure, Unintended
32
154
Obstruction/Occlusion
32
32
Patient Problem/Medical Problem
32
32
Stenosis
31
31
Vessel Or Plaque, Device Embedded In
31
31
Hematoma
29
29
Injury
28
28
Pseudoaneurysm
27
27
No Code Available
25
25
Vascular System (Circulation), Impaired
25
25
Iatrogenic Source
23
23
Aneurysm
20
20
Unspecified Tissue Injury
20
20
Hemorrhage/Bleeding
19
19
Restenosis
18
18
Vasoconstriction
15
15
Myocardial Infarction
15
15
Occlusion
14
14
Ischemia
11
11
Fistula
11
11
Low Blood Pressure/ Hypotension
10
10
Thromboembolism
10
10
Extravasation
10
10
Rupture
9
9
Reocclusion
9
9
Thrombus
8
8
Intimal Dissection
7
7
Death
7
7
Thrombosis
7
7
Sepsis
6
6
Cardiac Arrest
6
6
Renal Failure
6
6
Swelling/ Edema
5
5
Embolus
4
4
Foreign Body Embolism
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardiovascular Systems Inc
II
Aug-28-2021
2
Spectranetics Corporation
II
Dec-08-2023
3
ev3 Inc.
I
Mar-07-2022
4
ev3 Inc.
I
Jan-19-2022
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