XenoSure Biologic Patch e4P4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663106318), received between May 6, 2025 and May 6, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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.

• MalfunctionMay 6, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE PATCH WAS IMPLANTED DURING A HECTIC CODE PERFUSION CRITICAL LAPAROTOMY (POST KIDNEY TRANSPLANT) WHERE PATIENT PRESENTED IN HEMORRHAGIC SHOCK PRE-OP. A SAMPLE OF THE GRAFT WAS SENT AFTER BEING OPENED (AND ADMITTEDLY HANDLED BY MULTIPLE PEOPLE; IN CONTACT WITH PATIENT AND PATIENT CONTAMINATED INSTRUMENTS/GLOVES). SAID SAMPLE CAME BACK POSITIVE FOR CULTURED OF CANDIDA FUNGUS. GRAFT WAS ALREADY IMPLANTED. NO UNUSUAL HARM OR INJURY HAS BEEN CAUSED BY THE INCIDENT AND PATIENT HAS SINCE BEEN DISCHARGED.

  Patient problems: Bacterial Infection

  MAUDE report 21968530 ↗