XenoSure Biologic Patch e2P9Recalls & reported problems

Lemaitre Vascular, Inc. · XenoSure Biologic Patch, 2cm x 9cm, 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 00840663106301), received between May 29, 2025 and May 29, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Patient Device Interaction Problem1

Patient problems

Medical device site infection1

Recent adverse event reports

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

InjuryMay 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPH INFECTION FOLLOWING IMPLANTATION OF A 2X9 XENOSURE BIOLOGIC PATCH. ORIGINAL PROCEDURE WAS ON (B)(6) 2025 FOR A FEMORAL ENDARTERECTOMY WITH PATCH ANGIOPLASTY AND STENTING. THE PATIENT RETURNED ON (B)(6) 2025 FOR AN INCISION AND DRAINAGE OF THE WOUND. THE PATIENT WAS DISCHARGED HOME WITH A WOUND VAC AND THE WOUND IS IMPROVING. THE PATIENT IS STILL ON ANTIBIOTICS. THE PATCH REMAINS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 22107422 ↗

Device details

UDI-DI	`00840663106301`
Brand	XenoSure Biologic Patch
Model	e2P9
Company	Lemaitre Vascular, Inc.
Product code	FTM · Mesh, Surgical
Class	Class 2
FDA submission	K040835
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 21, 2021

Device type (GMDN): Cardiovascular patch, animal-derived

An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

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