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XENMATRIX 1150606Recalls & reported problems

Davol Inc. · XenMatrix AB Surgical Graft, 6 cm x 6 cm · Class 2 · Implant

All models of XENMATRIX (20)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741074172), received between Jul 9, 2019 and Jul 9, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Material Split, Cut or Torn1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 9, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

    AS REPORTED, DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR WHILE USING XENMATRIX AB GRAFT, IT "RIPPED" WHEN DEPLOYED DOWN A 12 MM PORT. THE GRAFT WAS REMOVED AND ANOTHER XENMATRIX AB GRAFT WAS THEN USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8771008 ↗

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Sources and updates

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