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TPLC
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show TPLC since
2009
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2014
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2024
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Device
catheter, coronary, atherectomy
Product Code
MCX
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
10
5
12
10
13
18
25
16
23
13
15
20
9
12
18
4
MDR Year
MDR Reports
MDR Events
2014
412
412
2015
629
629
2016
713
713
2017
735
735
2018
875
875
2019
788
788
2020
822
822
2021
901
901
2022
720
720
2023
708
708
2024
264
264
Device Problems
MDRs with this Device Problem
Events in those MDRs
Entrapment of Device
1970
1970
Adverse Event Without Identified Device or Use Problem
1429
1429
Material Separation
602
602
Fracture
559
559
Device Damaged by Another Device
523
523
Detachment of Device or Device Component
453
453
Output Problem
374
374
Difficult to Remove
245
245
Detachment Of Device Component
207
207
Device Operates Differently Than Expected
207
207
No Display/Image
168
168
Break
164
164
Failure to Advance
158
158
Material Deformation
150
150
Intermittent Loss of Power
141
141
Material Integrity Problem
126
126
Mechanical Problem
118
118
Noise, Audible
103
103
Display or Visual Feedback Problem
100
100
Device Contamination with Chemical or Other Material
91
91
Unintended System Motion
88
88
Difficult to Advance
85
85
Fluid/Blood Leak
81
81
Defective Device
65
65
Physical Resistance/Sticking
57
57
Kinked
55
55
Leak/Splash
52
52
Device Displays Incorrect Message
51
51
Unstable
51
51
Aspiration Issue
44
44
Gas/Air Leak
38
38
Mechanical Jam
37
37
Device Damaged Prior to Use
36
36
Material Split, Cut or Torn
36
36
Insufficient Information
34
34
Positioning Problem
31
31
Contamination
27
27
Sticking
27
27
Stretched
27
27
Defective Component
24
24
Device-Device Incompatibility
23
23
Difficult to Insert
20
20
Unsealed Device Packaging
19
19
Torn Material
19
19
Suction Problem
18
18
Physical Resistance
16
16
Unintended Movement
16
16
Material Twisted/Bent
15
15
Hole In Material
15
15
Infusion or Flow Problem
14
14
Use of Device Problem
12
12
Material Fragmentation
12
12
Unexpected Shutdown
11
11
Failure to Prime
10
10
Device Dislodged or Dislocated
9
9
Connection Problem
8
8
Material Rupture
8
8
Air Leak
8
8
Thermal Decomposition of Device
7
7
Device Remains Activated
7
7
Improper Flow or Infusion
7
7
Power Problem
6
6
Packaging Problem
6
6
Device Contaminated During Manufacture or Shipping
5
5
Difficult to Open or Close
5
5
Device Markings/Labelling Problem
5
5
Device Packaging Compromised
5
5
Device Contamination with Body Fluid
5
5
Tear, Rip or Hole in Device Packaging
5
5
Device Difficult to Setup or Prepare
5
5
Off-Label Use
5
5
Peeled/Delaminated
5
5
Overheating of Device
5
5
Unraveled Material
5
5
Failure to Power Up
4
4
Delivered as Unsterile Product
4
4
Bent
4
4
Backflow
4
4
Crack
4
4
Migration or Expulsion of Device
4
4
Obstruction of Flow
4
4
Difficult or Delayed Activation
4
4
Failure to Disconnect
4
4
Insufficient Flow or Under Infusion
4
4
Failure to Shut Off
4
4
No Apparent Adverse Event
3
3
Appropriate Term/Code Not Available
3
3
Malposition of Device
3
3
No Flow
3
3
Improper or Incorrect Procedure or Method
3
3
Excess Flow or Over-Infusion
3
3
Positioning Failure
3
3
Occlusion Within Device
3
3
Pumping Stopped
3
3
Material Puncture/Hole
3
3
Activation Problem
3
3
Air/Gas in Device
3
3
Poor Visibility
2
2
Program or Algorithm Execution Failure
2
2
Complete Loss of Power
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
2637
2637
No Clinical Signs, Symptoms or Conditions
1516
1516
Perforation of Vessels
808
808
Foreign Body In Patient
643
643
Device Embedded In Tissue or Plaque
423
423
Death
357
357
Vascular Dissection
341
341
No Patient Involvement
291
291
No Known Impact Or Consequence To Patient
277
277
Low Blood Pressure/ Hypotension
175
175
Perforation
128
128
Chest Pain
128
128
No Code Available
110
110
Cardiac Arrest
105
105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
97
97
Myocardial Infarction
78
78
Pericardial Effusion
73
73
Bradycardia
70
70
Cardiac Perforation
67
67
Insufficient Information
59
59
Hematoma
59
59
Intimal Dissection
58
58
Thrombus
58
58
Cardiac Tamponade
51
51
Obstruction/Occlusion
49
49
Ventricular Fibrillation
49
49
Vascular System (Circulation), Impaired
44
44
Hemorrhage/Bleeding
34
34
Non specific EKG/ECG Changes
33
33
ST Segment Elevation
25
25
Pain
22
22
Thrombosis/Thrombus
21
21
Arrhythmia
20
20
Ischemia
19
19
Thrombosis
18
18
Pseudoaneurysm
17
17
Tachycardia
16
16
Renal Failure
16
16
Cardiopulmonary Arrest
15
15
No Information
14
14
Embolism/Embolus
13
13
Vessel Or Plaque, Device Embedded In
13
13
Vasoconstriction
12
12
Cardiogenic Shock
12
12
Injury
11
11
Ventricular Tachycardia
11
11
Loss of consciousness
10
10
High Blood Pressure/ Hypertension
9
9
Occlusion
9
9
Pulmonary Edema
8
8
Dyspnea
8
8
Discomfort
8
8
Hematuria
7
7
Embolism
7
7
Extravasation
7
7
Stroke/CVA
7
7
Calcium Deposits/Calcification
7
7
Aneurysm
7
7
Angina
6
6
Hemolysis
6
6
Cardiac Enzyme Elevation
6
6
Hypersensitivity/Allergic reaction
6
6
Blood Loss
6
6
Diminished Pulse Pressure
6
6
Complaint, Ill-Defined
6
6
Great Vessel Perforation
6
6
Stenosis
5
5
Patient Problem/Medical Problem
5
5
Asystole
5
5
Heart Failure/Congestive Heart Failure
5
5
Vomiting
5
5
Atrial Fibrillation
5
5
Air Embolism
4
4
Respiratory Distress
4
4
Heart Block
4
4
Aortic Dissection
4
4
Loss Of Pulse
3
3
Rupture
3
3
Diaphoresis
3
3
Restenosis
3
3
Sepsis
3
3
Shock
3
3
Laceration(s)
3
3
Nausea
3
3
Left Ventricular Failure
2
2
Inflammation
2
2
Pleural Effusion
2
2
Exsanguination
2
2
Encephalopathy
2
2
Hemoptysis
2
2
Fistula
2
2
Unspecified Tissue Injury
2
2
Respiratory Arrest
2
2
Unspecified Heart Problem
2
2
Unspecified Vascular Problem
2
2
Ischemia Stroke
2
2
Sudden Cardiac Death
2
2
Low Oxygen Saturation
2
2
Dizziness
2
2
ST Segment Depression
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Apr-12-2022
2
Boston Scientific Corporation
II
Dec-15-2021
3
Boston Scientific Corporation
II
Dec-19-2019
4
Boston Scientific Corporation
II
Mar-03-2017
5
Boston Scientific Corporation
I
Nov-13-2015
6
Cardiovascular Systems Inc
II
Sep-11-2018
7
Cardiovascular Systems Inc
II
May-20-2017
8
Cardiovascular Systems, Inc.
I
Mar-20-2015
9
Cardiovascular Systems, Inc.
III
Feb-26-2014
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