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TPLC
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show TPLC since
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2024
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Device
glue, surgical, arteries
Product Code
MUQ
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
5
0
2
1
1
0
MDR Year
MDR Reports
MDR Events
2019
39
39
2020
25
25
2021
25
25
2022
12
12
2023
7
7
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
77
77
Insufficient Information
32
32
Appropriate Term/Code Not Available
7
7
Off-Label Use
6
6
Material Fragmentation
3
3
Migration
3
3
Material Separation
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Patient-Device Incompatibility
1
1
Biocompatibility
1
1
Chemical Problem
1
1
Device Damaged by Another Device
1
1
Material Deformation
1
1
Leak/Splash
1
1
Loss of or Failure to Bond
1
1
Clumping in Device or Device Ingredient
1
1
Patient Device Interaction Problem
1
1
Unintended Movement
1
1
Material Too Soft/Flexible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pseudoaneurysm
30
30
Inflammation
11
11
Death
10
10
Aneurysm
8
8
Embolism
6
6
Unspecified Infection
6
6
Reaction
6
6
No Code Available
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Insufficient Information
5
5
Thromboembolism
5
5
Fistula
5
5
Cerebrospinal Fluid Leakage
4
4
Anaphylactic Shock
4
4
Stroke/CVA
3
3
Aortic Dissection
3
3
Pain
3
3
Necrosis
3
3
No Information
3
3
Myocardial Infarction
2
2
Foreign Body In Patient
2
2
Embolism/Embolus
2
2
Reaction to Medicinal Component of Device
2
2
Swelling/ Edema
2
2
Neurological Deficit/Dysfunction
2
2
Blood Loss
2
2
Obstruction/Occlusion
2
2
Aortic Regurgitation
2
2
Fever
2
2
Ischemia
2
2
Seroma
2
2
Spinal Column Injury
1
1
Urinary Tract Infection
1
1
Loss of Vision
1
1
Weakness
1
1
Tingling
1
1
HIV, Human Immunodeficiency Virus
1
1
No Consequences Or Impact To Patient
1
1
Rupture
1
1
Discharge
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Stenosis
1
1
Urticaria
1
1
Injury
1
1
Meningitis
1
1
Itching Sensation
1
1
Mitral Regurgitation
1
1
Muscle Weakness
1
1
Embolus
1
1
Erythema
1
1
Arrhythmia
1
1
Atherosclerosis
1
1
Bacterial Infection
1
1
Calcium Deposits/Calcification
1
1
Infarction, Cerebral
1
1
Abscess
1
1
Chest Pain
1
1
Cyst(s)
1
1
Purulent Discharge
1
1
Granuloma
1
1
Hepatitis
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoxia
1
1
Spinal Cord Injury
1
1
Tissue Breakdown
1
1
Fluid Discharge
1
1
Occlusion
1
1
Undesired Nerve Stimulation
1
1
Pneumonia
1
1
Pulmonary Valve Stenosis
1
1
Coma
1
1
Cancer
1
1
Speech Disorder
1
1
Foreign Body Embolism
1
1
Thrombosis/Thrombus
1
1
Aortic Valve Insufficiency/ Regurgitation
1
1
Solid Tumour
1
1
Unspecified Tissue Injury
1
1
Valvular Stenosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CryoLife, Inc.
II
Dec-15-2021
2
Siemens Medical Solutions USA, Inc
II
Nov-16-2021
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