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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device glue, surgical, arteries
Product CodeMUQ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 1 0 1 1 0 1 5 3 3 5 0 2 1 1 0

MDR Year MDR Reports MDR Events
2014 40 40
2015 56 56
2016 28 28
2017 31 31
2018 25 25
2019 39 39
2020 25 25
2021 25 25
2022 12 12
2023 7 7
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 183 183
Insufficient Information 62 62
Appropriate Term/Code Not Available 24 24
Device Operates Differently Than Expected 10 10
Failure To Adhere Or Bond 7 7
Off-Label Use 6 6
Material Fragmentation 5 5
Migration or Expulsion of Device 4 4
Migration 3 3
Use of Device Problem 3 3
Loss of or Failure to Bond 3 3
Patient-Device Incompatibility 3 3
Material Separation 2 2
Improper or Incorrect Procedure or Method 2 2
Contamination 2 2
Material Deformation 2 2
Device Contamination with Chemical or Other Material 1 1
Material Too Soft/Flexible 1 1
Chemical Problem 1 1
Leak/Splash 1 1
Malposition of Device 1 1
Break 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Patient Device Interaction Problem 1 1
Degraded 1 1
Occlusion Within Device 1 1
Incorrect Or Inadequate Test Results 1 1
Device Damaged by Another Device 1 1
Improper Chemical Reaction 1 1
Biocompatibility 1 1
Peeled/Delaminated 1 1
Clumping in Device or Device Ingredient 1 1
Kinked 1 1
Complete Blockage 1 1
Material Erosion 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pseudoaneurysm 63 63
Unspecified Infection 49 49
Inflammation 27 27
Death 22 22
No Code Available 15 15
Embolism 15 15
Fever 14 14
No Information 12 12
Reaction 11 11
Aneurysm 10 10
Necrosis 9 9
Rupture 8 8
Anaphylactic Shock 7 7
Cerebrospinal Fluid Leakage 7 7
Vascular Dissection 7 7
Aortic Dissection 7 7
Abscess 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Fistula 6 6
Pain 6 6
Insufficient Information 6 6
Blood Loss 6 6
Stroke/CVA 5 5
Seroma 5 5
Thromboembolism 5 5
Myocardial Infarction 4 4
Neurological Deficit/Dysfunction 4 4
Ischemia 4 4
Fluid Discharge 3 3
Calcium Deposits/Calcification 3 3
Chest Pain 3 3
Foreign Body In Patient 3 3
No Known Impact Or Consequence To Patient 3 3
Hemorrhage/Bleeding 3 3
Meningitis 3 3
Aortic Regurgitation 3 3
Wound Dehiscence 3 3
Occlusion 3 3
Brain Injury 3 3
Not Applicable 3 3
Hypersensitivity/Allergic reaction 3 3
Granuloma 3 3
Embolism/Embolus 2 2
Purulent Discharge 2 2
No Consequences Or Impact To Patient 2 2
Bacterial Infection 2 2
Reaction to Medicinal Component of Device 2 2
Obstruction/Occlusion 2 2
Tissue Damage 2 2
Alteration In Body Temperature 2 2

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Dec-15-2021
2 CryoLife, Inc. II Jul-26-2018
3 CryoLife, Inc. II Jun-23-2017
4 CryoLife, Inc. II May-30-2014
5 Siemens Medical Solutions USA, Inc II Nov-16-2021
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