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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, anastomotic, microvascular
Product CodeMVR
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER/ SYNOVIS MICRO COMPANIES ALLIANCE INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNOVIS LIFE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIOPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 26 26
2015 40 40
2016 22 22
2017 13 13
2018 13 13
2019 44 50
2020 43 43
2021 35 35
2022 18 18
2023 28 28
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 68 68
Adverse Event Without Identified Device or Use Problem 51 51
Material Twisted/Bent 31 31
Disconnection 29 35
Difficult to Open or Close 15 15
Detachment of Device or Device Component 13 13
Device Dislodged or Dislocated 12 12
Break 11 11
Incomplete or Inadequate Connection 10 10
Fitting Problem 7 7
Loose or Intermittent Connection 7 7
Activation, Positioning or Separation Problem 6 6
Connection Problem 3 3
Failure to Sense 3 3
Misconnection 3 3
Defective Component 3 3
Material Deformation 3 3
Failure to Disconnect 2 2
Crack 2 2
Device Slipped 2 2
Fluid/Blood Leak 2 2
Obstruction of Flow 2 2
Component Missing 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Ejection 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Fire 1 1
Failure to Advance 1 1
Device Inoperable 1 1
Product Quality Problem 1 1
False Positive Result 1 1
Bent 1 1
Naturally Worn 1 1
Delivery System Failure 1 1
Difficult To Position 1 1
Failure to Align 1 1
Defective Device 1 1
Device Alarm System 1 1
Failure to Conduct 1 1
Material Rupture 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Entrapment of Device 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Mechanical Jam 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 71 71
No Clinical Signs, Symptoms or Conditions 69 69
No Consequences Or Impact To Patient 55 61
Injury 20 20
No Patient Involvement 17 17
Complaint, Ill-Defined 12 12
Thrombosis 10 10
Tissue Damage 7 7
Perforation of Vessels 5 5
Thrombus 5 5
Insufficient Information 3 3
No Information 3 3
Necrosis Of Flap Tissue 2 2
Occlusion 1 1
Intimal Dissection 1 1
Foreign Body Sensation in Eye 1 1
Ischemia 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Blood Loss 1 1
Discomfort 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-30-2021
2 Baxter Healthcare Corporation II Jun-30-2020
3 Baxter Healthcare Corporation II Apr-08-2020
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