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XenoSure Biologic Patch e10P16Recalls & reported problems

Lemaitre Vascular, Inc. · XenoSure Biologic Patch, 10cm x 16cm, eIFU · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663106349), received between Sep 7, 2023 and Sep 7, 2023 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DURING LITERATURE REVIEW THE ARTICLE INDICATED THAT ONE LIMB (2%) WITHOUT POSTOPERATIVE WOUND COMPLICATIONS REQUIRED ADDITIONAL TREATMENT DUE TO ACUTE BLEEDING DURING A STUDY TITLED "CLINICAL OUTCOMES OF COMMON FEMORAL THROMBOENDARTERECTOMY WITH BOVINE PERICARDIUM PATCH ANGIOPLASTY".

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 17698111 ↗

Other Mesh, Surgical devices

All Mesh, Surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.