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TPLC
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Device
prosthesis, vascular graft, of 6mm and greater diameter
Regulation Description
Vascular graft prosthesis.
Product Code
DSY
Regulation Number
870.3450
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATRIUM MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
PECA LABS
SUBSTANTIALLY EQUIVALENT
2
PECA LABS, INC.
SUBSTANTIALLY EQUIVALENT
1
VASCUTEK LTD
SUBSTANTIALLY EQUIVALENT
1
VASCUTEK LTD.
SUBSTANTIALLY EQUIVALENT
2
W. L. GORE & ASSOCIATES INC.
SUBSTANTIALLY EQUIVALENT
1
W. L. GORE & ASSOCIATES, INC.
SUBSTANTIALLY EQUIVALENT
2
W.L. GORE & ASSOCIATES, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
169
169
2021
168
168
2022
155
155
2023
149
149
2024
155
155
2025
41
41
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
121
121
Peeled/Delaminated
91
91
Obstruction of Flow
69
69
Insufficient Information
56
56
Material Split, Cut or Torn
51
51
Patient-Device Incompatibility
47
47
Complete Blockage
42
42
Contamination
37
37
Material Integrity Problem
36
36
Microbial Contamination of Device
36
36
Material Puncture/Hole
34
34
Material Separation
30
30
Product Quality Problem
27
27
Nonstandard Device
24
24
Partial Blockage
20
20
Off-Label Use
19
19
Patient Device Interaction Problem
19
19
Flaked
17
17
Device Stenosis
16
16
Use of Device Problem
16
16
Leak/Splash
14
14
Fluid/Blood Leak
14
14
Material Deformation
11
11
Manufacturing, Packaging or Shipping Problem
11
11
Appropriate Term/Code Not Available
11
11
Material Perforation
10
10
Defective Device
10
10
Mechanical Problem
9
9
Device Damaged Prior to Use
9
9
Migration
9
9
Infusion or Flow Problem
8
8
Material Frayed
7
7
Material Rupture
6
6
Material Fragmentation
5
5
Inaccurate Information
5
5
Improper or Incorrect Procedure or Method
5
5
Contamination /Decontamination Problem
4
4
Shipping Damage or Problem
4
4
Device Contamination with Chemical or Other Material
4
4
Detachment of Device or Device Component
4
4
Material Twisted/Bent
4
4
Device Markings/Labelling Problem
4
4
No Apparent Adverse Event
3
3
Human-Device Interface Problem
3
3
Labelling, Instructions for Use or Training Problem
3
3
Packaging Problem
3
3
Deformation Due to Compressive Stress
3
3
Compatibility Problem
3
3
Missing Information
2
2
Fracture
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
219
219
Thrombosis/Thrombus
105
105
Hemorrhage/Bleeding
90
90
Obstruction/Occlusion
61
61
Unspecified Infection
54
54
Insufficient Information
48
48
Bacterial Infection
43
43
Hematoma
33
33
Stenosis
32
32
Pseudoaneurysm
28
28
Seroma
23
23
No Consequences Or Impact To Patient
21
21
Occlusion
19
19
Thrombosis
17
17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Ischemia
14
14
Vascular Dissection
13
13
No Code Available
13
13
No Patient Involvement
12
12
Aneurysm
11
11
Pain
9
9
Post Operative Wound Infection
9
9
Wound Dehiscence
8
8
Thrombus
8
8
Blood Loss
8
8
Failure of Implant
7
7
Inflammation
6
6
Death
6
6
Sepsis
5
5
No Information
5
5
Failure to Anastomose
5
5
Rupture
5
5
Swelling/ Edema
4
4
Heart Failure/Congestive Heart Failure
4
4
Ischemia Stroke
4
4
Abdominal Pain
4
4
Fever
4
4
Perforation of Vessels
3
3
Erosion
3
3
Renal Failure
3
3
Fistula
3
3
Foreign Body In Patient
3
3
Purulent Discharge
3
3
Hypersensitivity/Allergic reaction
3
3
No Known Impact Or Consequence To Patient
2
2
Rash
2
2
High Blood Pressure/ Hypertension
2
2
Syncope/Fainting
2
2
Quadriplegia
2
2
Low Blood Pressure/ Hypotension
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Jun-04-2024
2
Atrium Medical Corporation
II
Sep-29-2021
3
Maquet Cardiovascular, LLC
II
Mar-10-2023
4
Maquet Cardiovascular, LLC
II
Jun-23-2022
5
Vascutek, Ltd.
II
Sep-24-2021
6
W L Gore & Associates, Inc.
II
Aug-13-2021
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