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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tissue graft of 6mm and greater
Product CodeLXA
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
1 0 1 4 3 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 6 6
2022 8 8
2023 12 12
2024 16 16
2025 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 35 35
Insufficient Information 14 14
Material Puncture/Hole 11 11
Material Rupture 2 2
Contamination 2 2
Obstruction of Flow 2 2
Fluid/Blood Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Nonstandard Device 1 1
No Apparent Adverse Event 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Obstruction/Occlusion 9 9
Insufficient Information 7 7
Thrombosis/Thrombus 6 6
Thromboembolism 6 6
Pseudoaneurysm 6 6
Unspecified Infection 5 5
Hematoma 5 5
Hemorrhage/Bleeding 5 5
Seroma 5 5
Aneurysm 4 4
Bacterial Infection 4 4
Stenosis 2 2
Vascular Dissection 2 2
Post Operative Wound Infection 2 2
No Known Impact Or Consequence To Patient 2 2
Rupture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. II Oct-23-2025
2 LeMaitre Vascular, Inc. II Oct-08-2025
3 LeMaitre Vascular, Inc. II Oct-02-2025
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