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TPLC
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2024
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Device
patch, pledget and intracardiac, petp, ptfe, polypropylene
Product Code
DXZ
Regulation Number
870.3470
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADMEDUS REGEN PTY LTD
SUBSTANTIALLY EQUIVALENT
1
VASCUTEK LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
55
55
2020
121
183
2021
80
80
2022
77
77
2023
40
40
2024
15
15
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
159
211
Device Contamination with Chemical or Other Material
57
57
Insufficient Information
35
35
Off-Label Use
27
35
Nonstandard Device
13
13
Improper or Incorrect Procedure or Method
12
12
Difficult to Open or Remove Packaging Material
12
12
Peeled/Delaminated
8
8
Unsealed Device Packaging
8
8
Material Rupture
7
7
Tear, Rip or Hole in Device Packaging
7
7
Use of Device Problem
7
9
Material Split, Cut or Torn
6
6
Patient Device Interaction Problem
5
5
Detachment of Device or Device Component
5
5
Appropriate Term/Code Not Available
5
5
Fluid/Blood Leak
5
5
Calcified
4
4
Packaging Problem
4
4
Product Quality Problem
4
4
Leak/Splash
4
4
Break
3
3
Migration or Expulsion of Device
3
3
Thickening of Material
3
3
Material Deformation
3
3
Contamination /Decontamination Problem
3
3
Structural Problem
3
3
Material Puncture/Hole
3
3
Material Disintegration
3
3
Migration
2
2
Material Separation
2
2
Lack of Effect
2
2
Degraded
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Integrity Problem
2
2
Patient-Device Incompatibility
2
2
Crack
2
2
Obstruction of Flow
2
2
Material Too Rigid or Stiff
2
2
Delivered as Unsterile Product
2
2
Material Erosion
1
1
Restricted Flow rate
1
1
Shipping Damage or Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Separation Problem
1
1
Material Frayed
1
1
Biocompatibility
1
1
Fracture
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Moisture Damage
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
83
83
Stenosis
67
91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Unspecified Infection
18
18
Aortic Valve Insufficiency/ Regurgitation
14
19
Inflammation
14
14
Pseudoaneurysm
11
11
Hematoma
11
11
Restenosis
10
33
Aortic Valve Stenosis
10
10
Mitral Valve Insufficiency/ Regurgitation
10
10
Hemorrhage/Bleeding
10
15
Insufficient Information
9
11
Thrombosis/Thrombus
9
19
No Patient Involvement
8
8
No Code Available
8
8
Pain
7
7
No Known Impact Or Consequence To Patient
7
7
Mitral Valve Stenosis
7
7
Endocarditis
7
7
Injury
6
6
Failure of Implant
6
6
Wound Dehiscence
5
5
Arrhythmia
5
10
Seroma
5
5
Pulmonary Valve Insufficiency/ Regurgitation
5
5
No Consequences Or Impact To Patient
5
5
Adhesion(s)
5
5
Aneurysm
5
5
Valvular Insufficiency/ Regurgitation
5
12
Rupture
5
5
Reaction
4
4
Pericardial Effusion
4
4
Sepsis
4
14
Meningitis
4
4
Death
4
4
Unspecified Tissue Injury
3
3
Calcium Deposits/Calcification
3
3
Pneumonia
3
14
Unspecified Respiratory Problem
3
15
Dyspnea
3
3
Foreign Body Reaction
3
3
Nerve Damage
3
3
Chest Pain
3
3
Not Applicable
3
3
Aortic Insufficiency
3
3
Respiratory Insufficiency
2
2
Valvular Stenosis
2
2
Bacterial Infection
2
2
Thrombus
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Artivion, Inc
II
Aug-08-2024
2
Baxter Healthcare Corporation
II
Jan-05-2024
3
CryoLife, Inc.
II
Dec-21-2020
4
CryoLife, Inc.
II
Apr-25-2019
5
Vascutek, Ltd.
II
Sep-24-2021
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