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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
LEMAITRE VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
LIMFLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 19 19
2020 6 6
2021 2 2
2022 13 13
2023 23 23
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 21 21
Difficult to Open or Close 19 19
Adverse Event Without Identified Device or Use Problem 9 9
Failure to Align 5 5
Material Twisted/Bent 2 2
Connection Problem 2 2
Material Deformation 2 2
Break 2 2
Material Separation 1 1
Positioning Problem 1 1
Flare or Flash 1 1
Difficult to Flush 1 1
Leak/Splash 1 1
Sharp Edges 1 1
Defective Component 1 1
Material Perforation 1 1
Device Markings/Labelling Problem 1 1
Fluid/Blood Leak 1 1
Failure to Cut 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
No Known Impact Or Consequence To Patient 13 13
Perforation of Vessels 13 13
Laceration(s) 5 5
Insufficient Information 4 4
No Patient Involvement 3 3
No Consequences Or Impact To Patient 3 3
Injury 1 1
Vascular Dissection 1 1
No Information 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. II Aug-28-2023
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