XenoSure Biologic Patch e6P8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663106806), received between Apr 28, 2026 and Apr 28, 2026 — 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.

Most reported problems

Recent adverse event reports

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

• InjuryApr 28, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE XENOSURE TESTED POSITIVE ON CULTURE FOR CUTIBACTERIUM ACNES. THE CAUSE WAS ATTRIBUTED TO POSSIBLE OR CONTAMINATION. THE PRODUCT WAS IMPLANTED. IT IS NOT KNOWN WHAT ACTIONS, IF ANY, WERE TAKEN TO TREAT OR RESOLVE THE INFECTION, AS SPECIFIC DETAILS OF THE EVENT WERE NOT PROVIDED. NO OTHER PATIENT INJURY OR COMPLICATIONS WAS REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 25016969 ↗