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TPLC
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Device
catheter, angioplasty, peripheral, transluminal
Product Code
LIT
Regulation Number
870.1250
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT VASCULAR
SUBSTANTIALLY EQUIVALENT
1
BARD PERIPHERAL VASCULAR, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOTRONIK, INC.
SUBSTANTIALLY EQUIVALENT
2
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BROSMED MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
CONTEGO MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
CORDIS CORPORATION
SUBSTANTIALLY EQUIVALENT
3
CORDIS US CORP.
SUBSTANTIALLY EQUIVALENT
1
CREAGH MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
CREAGH MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
SUBSTANTIALLY EQUIVALENT
1
DK MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
INFINITY ANGIOPLASTY BALLOON COMPANY, LLC
SUBSTANTIALLY EQUIVALENT
1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
KOSSEL MEDTECH (SUZHOU) CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC VASCULAR,INC(FORMERLY D.B.A EV3 INC.,COVIDIEN LLC)
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC. (FORMERLY D.B.A. EV3 INC, COVIDIEN LLC.)
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
NATEC MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
NEXSTEP MEDICAL
SUBSTANTIALLY EQUIVALENT
1
NIPRO MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
QUALIMED USA, LLC.
SUBSTANTIALLY EQUIVALENT
1
SILK ROAD MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SUMMA THERAPEUTICS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
2405
2405
2020
2443
2443
2021
2492
2492
2022
2155
2155
2023
1803
1803
2024
416
416
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
7227
7227
Burst Container or Vessel
1685
1685
Difficult to Remove
636
636
Detachment of Device or Device Component
629
629
Leak/Splash
614
614
Break
366
366
Adverse Event Without Identified Device or Use Problem
362
362
Inflation Problem
280
280
Deflation Problem
277
277
Material Separation
268
268
Material Deformation
230
230
Difficult to Advance
161
161
Failure to Advance
145
145
Improper or Incorrect Procedure or Method
129
129
Entrapment of Device
118
118
Material Puncture/Hole
103
103
Retraction Problem
89
89
Material Twisted/Bent
88
88
Device-Device Incompatibility
82
82
Material Split, Cut or Torn
78
78
Material Integrity Problem
73
73
Fluid/Blood Leak
71
71
Fracture
58
58
Off-Label Use
48
48
Difficult to Insert
46
46
Use of Device Problem
45
45
Stretched
43
43
Device Dislodged or Dislocated
40
40
Material Frayed
38
38
Partial Blockage
28
28
Difficult to Open or Remove Packaging Material
27
27
Device Handling Problem
27
27
Failure to Deflate
27
27
Peeled/Delaminated
26
26
Failure to Fold
23
23
Structural Problem
21
21
Packaging Problem
21
21
Device Contamination with Chemical or Other Material
20
20
Device Damaged by Another Device
20
20
Crack
20
20
Device Damaged Prior to Use
17
17
Device Markings/Labelling Problem
16
16
Physical Resistance/Sticking
16
16
Device Contaminated During Manufacture or Shipping
13
13
Deformation Due to Compressive Stress
13
13
Defective Component
12
12
Unraveled Material
12
12
Component Missing
11
11
Mechanical Jam
10
10
Component Misassembled
9
9
Defective Device
9
9
Difficult to Open or Close
9
9
Decrease in Pressure
9
9
Material Fragmentation
8
8
Positioning Problem
8
8
Patient-Device Incompatibility
7
7
Contamination /Decontamination Problem
6
6
Tear, Rip or Hole in Device Packaging
6
6
Accessory Incompatible
6
6
Difficult to Flush
6
6
Product Quality Problem
4
4
Migration or Expulsion of Device
4
4
Suction Problem
4
4
Appropriate Term/Code Not Available
4
4
Migration
4
4
Separation Problem
3
3
Delivered as Unsterile Product
3
3
Unsealed Device Packaging
3
3
Device Difficult to Setup or Prepare
3
3
Mechanical Problem
3
3
Flaked
3
3
Degraded
2
2
Difficult or Delayed Positioning
2
2
Contamination
2
2
No Display/Image
2
2
Obstruction of Flow
2
2
Incomplete or Missing Packaging
2
2
Component or Accessory Incompatibility
2
2
Expiration Date Error
2
2
Device Fell
2
2
Patient Device Interaction Problem
2
2
Compatibility Problem
2
2
Pressure Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unintended Movement
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Explosion
1
1
Material Too Soft/Flexible
1
1
Sharp Edges
1
1
Air/Gas in Device
1
1
Poor Visibility
1
1
Separation Failure
1
1
Malposition of Device
1
1
Activation, Positioning or Separation Problem
1
1
Biocompatibility
1
1
Failure to Unfold or Unwrap
1
1
Material Too Rigid or Stiff
1
1
Complete Blockage
1
1
Failure to Back-Up
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6451
6451
No Consequences Or Impact To Patient
4150
4151
Insufficient Information
158
158
No Known Impact Or Consequence To Patient
141
141
Foreign Body In Patient
138
138
Vascular Dissection
137
137
No Patient Involvement
111
111
Device Embedded In Tissue or Plaque
89
89
Stenosis
74
74
Injury
54
54
No Code Available
50
50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
47
47
Perforation of Vessels
46
46
Hematoma
41
41
Embolism/Embolus
41
41
Hemorrhage/Bleeding
40
40
Patient Problem/Medical Problem
37
37
Thrombosis/Thrombus
34
34
Obstruction/Occlusion
33
33
Restenosis
29
29
Pain
25
25
Unspecified Tissue Injury
21
21
Thrombus
20
20
Perforation
18
18
Death
18
18
Occlusion
17
17
Stroke/CVA
15
15
Embolism
14
14
Pseudoaneurysm
14
14
Thrombosis
12
12
Reocclusion
10
10
Great Vessel Perforation
10
10
Rupture
9
9
Unspecified Infection
9
9
Myocardial Infarction
8
8
Low Blood Pressure/ Hypotension
8
8
Arrhythmia
8
8
Calcium Deposits/Calcification
7
7
Fistula
7
7
Aneurysm
6
6
Needle Stick/Puncture
6
6
Blood Loss
6
6
No Information
6
6
Swelling/ Edema
5
5
Bradycardia
5
5
Vessel Or Plaque, Device Embedded In
5
5
Intimal Dissection
5
5
Vasoconstriction
5
5
Renal Failure
5
5
Transient Ischemic Attack
4
4
Cardiac Arrest
4
4
Extravasation
4
4
High Blood Pressure/ Hypertension
4
4
Ischemia
4
4
Thromboembolism
4
4
Failure of Implant
3
3
Fever
3
3
Vomiting
3
3
Necrosis
3
3
Pneumonia
2
2
Pulmonary Edema
2
2
Sepsis
2
2
Tachycardia
2
2
Infarction, Cerebral
2
2
Diarrhea
2
2
Pulmonary Embolism
2
2
Inflammation
2
2
Nausea
2
2
Hypersensitivity/Allergic reaction
2
2
Hypoxia
2
2
Cardiac Perforation
2
2
Prolapse
2
2
Numbness
2
2
Post Operative Wound Infection
2
2
Arteriosclerosis/ Atherosclerosis
2
2
Hemorrhagic Stroke
1
1
Ruptured Aneurysm
1
1
Unspecified Vascular Problem
1
1
Asystole
1
1
Cardiovascular Insufficiency
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Foreign Body Embolism
1
1
Atrial Perforation
1
1
Hemorrhage, Cerebral
1
1
Itching Sensation
1
1
Laceration(s)
1
1
Infiltration into Tissue
1
1
Anaphylactic Shock
1
1
Cellulitis
1
1
Bruise/Contusion
1
1
Dyspnea
1
1
Ecchymosis
1
1
Ventricular Fibrillation
1
1
Cardiogenic Shock
1
1
Reaction
1
1
Physical Entrapment
1
1
Anxiety
1
1
Discomfort
1
1
Seroma
1
1
Skin Irritation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bard Peripheral Vascular Inc
II
Jan-30-2020
2
BrosMed Medical Co.,Ltd.
II
Feb-27-2019
3
Cordis Corporation
II
Aug-09-2021
4
Cordis Corporation
II
Feb-28-2020
5
Cordis Corporation
II
Oct-30-2019
6
Covidien Llc
II
Feb-03-2022
7
Nucryo Vascular Inc.
II
Nov-21-2019
8
Ostial Corporation
II
Aug-17-2021
9
ev3 Inc.
II
Sep-30-2020
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