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, 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
1
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
114
114
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
566
810
Break
542
1152
Entrapment of Device
496
496
Adverse Event Without Identified Device or Use Problem
440
1416
Material Separation
271
271
Material Deformation
238
360
Physical Resistance/Sticking
208
208
Difficult to Remove
205
205
Mechanical Problem
194
194
Mechanical Jam
153
153
Suction Problem
148
148
Fracture
111
111
Difficult to Advance
88
88
Device Damaged by Another Device
84
84
Noise, Audible
69
69
Use of Device Problem
63
63
Leak/Splash
58
58
Retraction Problem
43
43
Failure to Advance
42
42
Positioning Problem
38
38
Device Markings/Labelling Problem
28
28
Device-Device Incompatibility
25
25
Defective Device
25
25
Fluid/Blood Leak
24
24
Material Integrity Problem
23
23
Material Split, Cut or Torn
23
23
Unexpected Shutdown
23
23
Infusion or Flow Problem
20
20
Overheating of Device
20
20
Peeled/Delaminated
16
16
Intermittent Loss of Power
15
15
Device Difficult to Setup or Prepare
14
14
Off-Label Use
14
14
Material Puncture/Hole
13
13
Melted
13
13
Material Twisted/Bent
13
13
Deformation Due to Compressive Stress
12
12
No Apparent Adverse Event
12
12
Display or Visual Feedback Problem
11
11
Unintended System Motion
10
10
Difficult or Delayed Activation
10
10
Activation Problem
10
10
Insufficient Information
9
9
Device Displays Incorrect Message
9
9
Device Contamination with Chemical or Other Material
9
9
Failure to Prime
9
9
Stretched
9
9
Device Remains Activated
8
8
Contamination
8
8
Compatibility Problem
8
8
Therapeutic or Diagnostic Output Failure
8
8
Output Problem
8
8
Missing Information
8
8
No Flow
7
7
Improper or Incorrect Procedure or Method
7
7
Crack
7
251
Difficult to Insert
6
6
Material Perforation
6
6
Difficult to Open or Close
6
6
Unintended Movement
6
6
Air/Gas in Device
6
6
Inaccurate Information
6
6
Migration
5
5
Device Handling Problem
5
5
Device Dislodged or Dislocated
5
5
Connection Problem
5
5
Defective Component
5
5
Material Rupture
5
5
Material Fragmentation
4
4
Loss of or Failure to Bond
4
4
Obstruction of Flow
4
4
Device Contamination with Body Fluid
4
4
Insufficient Flow or Under Infusion
4
4
Activation, Positioning or Separation Problem
4
4
Appropriate Term/Code Not Available
4
4
Sharp Edges
4
4
Wrong Label
3
3
Temperature Problem
3
3
Activation Failure
3
3
Failure to Shut Off
3
3
Device Contaminated During Manufacture or Shipping
3
3
Power Problem
3
3
Failure to Calibrate
3
125
Contamination /Decontamination Problem
3
3
Complete Blockage
3
3
Material Frayed
3
3
Pumping Stopped
3
3
Energy Output Problem
2
2
Flaked
2
2
Difficult to Flush
2
2
Flushing Problem
2
2
Component Incompatible
2
2
Degraded
2
2
Malposition of Device
2
2
Patient-Device Incompatibility
2
2
Calibration Problem
2
2
Sparking
2
2
Misfire
2
2
Structural Problem
2
2
Solder Joint Fracture
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1417
2027
No Consequences Or Impact To Patient
623
623
Foreign Body In Patient
226
226
Vascular Dissection
150
516
Perforation of Vessels
131
253
No Known Impact Or Consequence To Patient
123
245
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
114
114
Embolism/Embolus
111
355
Device Embedded In Tissue or Plaque
109
109
Insufficient Information
72
72
Perforation
61
61
Embolism
58
180
Unintended Radiation Exposure
48
902
Thrombosis/Thrombus
40
40
Pain
34
34
Patient Problem/Medical Problem
32
32
Radiation Exposure, Unintended
32
154
Vessel Or Plaque, Device Embedded In
31
31
Injury
28
28
Obstruction/Occlusion
25
25
Vascular System (Circulation), Impaired
25
25
No Code Available
25
25
Iatrogenic Source
23
23
Pseudoaneurysm
19
19
Unspecified Tissue Injury
19
19
Restenosis
16
16
Hematoma
16
16
Aneurysm
15
15
Occlusion
14
14
Myocardial Infarction
13
13
Stenosis
13
13
Hemorrhage/Bleeding
12
12
Extravasation
10
10
Reocclusion
9
9
Rupture
9
9
Thromboembolism
9
9
Thrombus
8
8
Ischemia
8
8
Fistula
8
8
Low Blood Pressure/ Hypotension
8
8
Death
7
7
Intimal Dissection
7
7
Thrombosis
7
7
Vasoconstriction
6
6
Renal Failure
6
6
Sepsis
6
6
Cardiac Arrest
5
5
Swelling/ Edema
5
5
Foreign Body Embolism
4
4
Embolus
4
4
Intraoperative Pain
4
4
No Patient Involvement
4
4
Blood Loss
3
3
Fever
3
3
Hypersensitivity/Allergic reaction
3
3
Nausea
3
3
Muscle Spasm(s)
2
2
Calcium Deposits/Calcification
2
2
Ecchymosis
2
2
Stroke/CVA
2
2
Chest Pain
2
2
Arrhythmia
2
2
Discomfort
2
2
Tissue Damage
2
2
Burning Sensation
2
2
Great Vessel Perforation
1
1
Vomiting
1
1
Cardiac Tamponade
1
1
Anxiety
1
1
Tachycardia
1
1
Peripheral Vascular Disease
1
1
Diminished Pulse Pressure
1
1
Skin Tears
1
1
Claudication
1
1
Respiratory Failure
1
1
Loss of consciousness
1
1
Bradycardia
1
1
Bruise/Contusion
1
1
Pulmonary Embolism
1
1
Dyspnea
1
1
Exsanguination
1
1
Laceration(s)
1
1
High Blood Pressure/ Hypertension
1
1
Unspecified Infection
1
1
Bone Fracture(s)
1
1
Hyperplasia
1
1
Missing Value Reason
1
1
Arteriosclerosis/ Atherosclerosis
1
1
No Information
1
1
Unspecified Vascular Problem
1
1
Respiratory Arrest
1
1
Unspecified Kidney or Urinary Problem
1
1
Localized Skin Lesion
1
1
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
-
-