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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device valvulotome
Regulation Description External vein stripper.
Product CodeMGZ
Regulation Number 870.4885
Device Class 2


Premarket Reviews
ManufacturerDecision
AVEERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMFLOW, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 2 2
2022 13 13
2023 23 23
2024 3 3
2025 8 8
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 25 25
Adverse Event Without Identified Device or Use Problem 9 9
Difficult to Open or Close 5 5
Material Perforation 3 3
Material Twisted/Bent 2 2
Material Deformation 2 2
Connection Problem 2 2
Leak/Splash 1 1
Break 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Flare or Flash 1 1
Mechanics Altered 1 1
Sharp Edges 1 1
Detachment of Device or Device Component 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Perforation of Vessels 16 16
Insufficient Information 4 4
Vascular Dissection 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. II Aug-28-2023
2 LimFlow, Inc. II Jan-29-2026
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