XENMATRIX 1151010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741074219), received between Apr 25, 2018 and Apr 25, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT IS A (B)(6) BOY WHO WAS BORN PRE-TERM WITH SIGNIFICANT MEDICAL COMPLICATIONS. IN 2015, THE BOY UNDERWENT A MULTI-VISCERAL ORGAN TRANSPLANT. AS REPORTED, THE PATIENT REJECTED THIS ORGAN TRANSPLANT. IN (B)(6) 2017 HE UNDERWENT A SECOND MULTI-VISCERAL ORGAN TRANSPLANT PROCEDURE. DURING THIS PROCEDURE, A XENMATRIX AB GRAFT WAS IMPLANTED. THE PATIENT EXPERIENCED POST-OP COMPLICATIONS WITH FLUID ACCUMULATION IN THE AREA OF THE GRAFT. THIS WAS LATER IDENTIFIED AS AN INFECTION AT THE SITE. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 7459293 ↗