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TPLC
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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
1
AVINGER, INC.
SUBSTANTIALLY EQUIVALENT
8
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
6
CARDIOVASCULAR SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
EXIMO MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
5
EXIMO MEDICAL, LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC VASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
2
1. K161361
HawkOne Directional Atherectomy System
2. K170191
SilverHawk Peripheral Plaque Excision System, Turb
...
MEDTRONIC, INC
SUBSTANTIALLY EQUIVALENT
1
REX MEDICAL, L.P.
SUBSTANTIALLY EQUIVALENT
2
SPECTRANETICS INC.
SUBSTANTIALLY EQUIVALENT
1
SPECTRANETICS, INC.
SUBSTANTIALLY EQUIVALENT
4
STRAUB MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
VOLCANO ATHEROMED INC
SUBSTANTIALLY EQUIVALENT
1
VOLCANO ATHEROMED INC.
SUBSTANTIALLY EQUIVALENT
2
VOLCANO ATHEROMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
409
409
2017
415
415
2018
537
537
2019
618
618
2020
631
753
2021
734
2930
2022
566
566
2023
575
575
2024
145
145
Device Problems
MDRs with this Device Problem
Events in those MDRs
Entrapment of Device
745
745
Detachment of Device or Device Component
693
937
Adverse Event Without Identified Device or Use Problem
680
1656
Break
621
1231
Material Separation
405
405
Material Deformation
360
482
Difficult to Remove
256
256
Mechanical Problem
225
225
Physical Resistance/Sticking
213
213
Mechanical Jam
176
176
Suction Problem
170
170
Fracture
146
146
Device Damaged by Another Device
123
123
Difficult to Advance
99
99
Aspiration Issue
89
89
Noise, Audible
80
80
Device Operates Differently Than Expected
71
71
Leak/Splash
71
71
Use of Device Problem
70
70
Retraction Problem
52
52
Failure to Advance
47
47
Positioning Problem
42
42
Detachment Of Device Component
40
40
Defective Device
34
34
Device-Device Incompatibility
34
34
Material Integrity Problem
32
32
Device Markings/Labelling Problem
28
28
Material Twisted/Bent
26
26
Unexpected Shutdown
26
26
Fluid/Blood Leak
26
26
Material Split, Cut or Torn
25
25
Infusion or Flow Problem
24
24
Hole In Material
23
23
Overheating of Device
22
22
Peeled/Delaminated
22
22
Material Puncture/Hole
21
21
Intermittent Loss of Power
17
17
Material Rupture
16
16
Deformation Due to Compressive Stress
16
16
Melted
16
16
Off-Label Use
14
14
Device Difficult to Setup or Prepare
14
14
Improper or Incorrect Procedure or Method
14
14
Device Contamination with Chemical or Other Material
14
14
Device Dislodged or Dislocated
14
14
Insufficient Information
13
13
Device Remains Activated
13
13
Device Displays Incorrect Message
13
13
Display or Visual Feedback Problem
13
13
Unintended System Motion
12
12
No Apparent Adverse Event
12
12
Compatibility Problem
11
11
Crack
11
255
Difficult or Delayed Activation
11
11
Stretched
11
11
Material Fragmentation
10
10
Contamination
10
10
Difficult to Open or Close
10
10
Device Operational Issue
10
10
Unintended Movement
10
10
Activation Problem
10
10
Material Perforation
9
9
Failure to Prime
9
9
Material Frayed
8
8
Missing Information
8
8
Therapeutic or Diagnostic Output Failure
8
8
Output Problem
8
8
No Flow
7
7
Device Handling Problem
7
7
Complete Blockage
7
7
Migration or Expulsion of Device
7
7
Difficult to Insert
7
7
Defective Component
7
7
Obstruction of Flow
7
7
Appropriate Term/Code Not Available
6
6
Torn Material
6
6
Air/Gas in Device
6
6
Inaccurate Information
6
6
Migration
5
5
Connection Problem
5
5
Activation, Positioning or Separation Problem
5
5
Device Packaging Compromised
5
5
Material Protrusion/Extrusion
5
5
Device Stops Intermittently
5
5
Loss of or Failure to Bond
5
5
Kinked
5
5
Failure to Power Up
5
5
Contamination /Decontamination Problem
4
4
Failure to Calibrate
4
126
Device Contamination with Body Fluid
4
4
Insufficient Flow or Under Infusion
4
4
Device Inoperable
4
4
Failure to Shut Off
4
4
Device Misassembled During Manufacturing /Shipping
4
4
Activation Failure
4
4
Sharp Edges
4
4
Packaging Problem
4
4
Power Problem
3
3
Temperature Problem
3
3
Device Contaminated During Manufacture or Shipping
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1437
2047
No Consequences Or Impact To Patient
1277
1277
Foreign Body In Patient
331
331
No Known Impact Or Consequence To Patient
253
375
Vascular Dissection
215
581
Perforation of Vessels
182
304
Device Embedded In Tissue or Plaque
161
161
Embolism
126
248
Embolism/Embolus
114
358
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
114
114
Perforation
82
82
Insufficient Information
72
72
Patient Problem/Medical Problem
71
71
Reocclusion
63
63
No Code Available
59
59
Pain
50
50
Unintended Radiation Exposure
49
903
Radiation Exposure, Unintended
47
169
Vessel Or Plaque, Device Embedded In
46
46
Thrombosis/Thrombus
41
41
Injury
40
40
Occlusion
35
35
Intimal Dissection
31
31
No Patient Involvement
30
30
Vascular System (Circulation), Impaired
29
29
Pseudoaneurysm
29
29
Death
29
29
Stenosis
29
29
Thrombus
29
29
Obstruction/Occlusion
28
28
Hematoma
28
28
Iatrogenic Source
26
26
Unspecified Tissue Injury
19
19
Aneurysm
17
17
Restenosis
16
16
Embolus
15
15
Hemorrhage/Bleeding
14
14
Myocardial Infarction
14
14
Thromboembolism
14
14
Thrombosis
11
11
Low Blood Pressure/ Hypotension
11
11
Fistula
11
11
Tissue Damage
11
11
Extravasation
10
10
Ischemia
9
9
Rupture
9
9
Sepsis
8
8
Vasoconstriction
7
7
Cardiac Arrest
7
7
Renal Failure
6
6
Peripheral Vascular Disease
5
5
Blood Loss
5
5
Intraoperative Pain
5
5
Swelling/ Edema
5
5
No Information
5
5
Foreign Body Embolism
4
4
Fever
4
4
Stroke/CVA
4
4
Nausea
4
4
Calcium Deposits/Calcification
4
4
Hypersensitivity/Allergic reaction
3
3
Laceration(s)
2
2
Muscle Spasm(s)
2
2
Chest Pain
2
2
Dyspnea
2
2
Ecchymosis
2
2
Cardiopulmonary Arrest
2
2
Pulmonary Embolism
2
2
Arrhythmia
2
2
Tachycardia
2
2
Burning Sensation
2
2
Deformity/ Disfigurement
2
2
Atrial Perforation
2
2
Discomfort
2
2
Claudication
2
2
Alteration In Body Temperature
1
1
Superficial (First Degree) Burn
1
1
Diminished Pulse Pressure
1
1
Test Result
1
1
Unspecified Vascular Problem
1
1
Respiratory Arrest
1
1
Unspecified Kidney or Urinary Problem
1
1
Localized Skin Lesion
1
1
Missing Value Reason
1
1
Arteriosclerosis/ Atherosclerosis
1
1
Not Applicable
1
1
Complaint, Ill-Defined
1
1
Respiratory Acidosis
1
1
Respiratory Failure
1
1
Shaking/Tremors
1
1
Skin Tears
1
1
Sudden Cardiac Death
1
1
Disability
1
1
Loss of consciousness
1
1
Cardiac Tamponade
1
1
Cardiogenic Shock
1
1
Anxiety
1
1
Great Vessel Perforation
1
1
Nipple Sensation Changes
1
1
Heart Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Apr-10-2017
2
Cardiovascular Systems Inc
II
Aug-28-2021
3
Cardiovascular Systems Inc
II
Oct-11-2018
4
Cardiovascular Systems Inc
II
Apr-10-2017
5
Cardiovascular Systems Inc
II
Apr-10-2017
6
Cardiovascular Systems Inc
II
Feb-22-2017
7
Cardiovascular Systems Inc
II
Jun-27-2016
8
Micro Therapeutics Inc, Dba Ev3 Neurovascular
II
Sep-11-2018
9
Spectranetics Corp.
II
Feb-05-2016
10
Spectranetics Corporation
II
Dec-08-2023
11
Spectranetics Corporation
II
Jul-14-2017
12
Spectranetics Corporation
II
Nov-28-2016
13
ev3 Inc.
I
Mar-07-2022
14
ev3 Inc.
I
Jan-19-2022
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