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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device valvulotome
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
2018 7 7
2019 19 19
2020 6 6
2021 2 2
2022 13 13
2023 23 23
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 23 23
Retraction Problem 20 20
Adverse Event Without Identified Device or Use Problem 9 9
Failure to Align 5 5
Material Deformation 4 4
Break 2 2
Material Twisted/Bent 2 2
Connection Problem 2 2
Leak/Splash 1 1
Device Markings/Labelling Problem 1 1
Difficult to Flush 1 1
Insufficient Information 1 1
Defective Component 1 1
Positioning Problem 1 1
Flare or Flash 1 1
Material Perforation 1 1
Failure to Cut 1 1
Sharp Edges 1 1
Bent 1 1
Material Separation 1 1
Fluid/Blood Leak 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 15 15
Perforation of Vessels 14 14
Laceration(s) 6 6
No Information 4 4
Insufficient Information 4 4
No Patient Involvement 3 3
No Consequences Or Impact To Patient 3 3
Blood Loss 1 1
Injury 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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