XENMATRIX 1153045Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741129049), received between Jul 15, 2019 and Jul 15, 2019 — classified as 1 malfunction.

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.

• MalfunctionJul 15, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED AND IS ASSOCIATED WITH THE XENMATRIX AB STUDY DVL-HE-012: ON (B)(6) 2018 THE PATIENT WAS IMPLANTED WITH A BARD XENMATRIX AB GRAFT DURING HERNIA RECTO-RECTUS REVISION PROCEDURE FOR HERNIA RECURRENCE. AS REPORTED THE GRAFT WAS TRIMMED TO SIZE AND A 5CM GRAFT OVERLAP WAS MAINTAINED AROUND THE HERNIA DEFECT. IT IS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH LOWER RIGHT SIDED ABDOMINAL PAIN WHICH STARTED ON (B)(6) 2019. NO ACTION IS BEING TAKEN AND NO INTERVENTION IS REQUIRED AT THIS TIME. THE PATIENT SYMPTOM OF PAIN HAS BEEN ASSESSED BY THE CLINICIAN AS MILD IN SEVERITY, "POSSIBLY RELATED" TO THE STUDY DEVICE AND "POSSIBLY RELATED" TO THE PROCEDURE. AS REPORTED, THE PAIN IS MILD IN NATURE AND COMES AND GOES. "POINT TENDERNESS AT ABOUT THE SUBCOSTAL SITE OF MESH FIXATION."

  Patient problems: Pain

  MAUDE report 8789523 ↗