XENMATRIX 1160610Recalls & reported problems
Davol Inc. · XenMatrix Surgical Graft, 6 cm x 10 cm (2.4" x 3.9" ), Rectangle · 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 00801741074349), received between Jun 11, 2025 and Jun 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED, ON 18-APR-2025 WHEN THE XENMATRIX SURGICAL GRAFT WAS OPENED IT WAS FOUND THAT THE OUTER PACKAGE OF THE PATCH WAS DAMAGED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185052 ↗
Other Mesh, surgical, collagen, diaphragmatic hernia devices
- Biodesign G31455Cook Biotech Incorporated · Mesh, surgical, collagen, diaphragmatic hernia1 recall1 report
- Supple Peri-Guard PC1016SNSynovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Supple Peri-Guard PC0608SNSynovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Peri-Guard PG1225Synovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Peri-Guard PG0404Synovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- Peri-Guard PG1016Synovis Life Technologies, Inc. · Mesh, surgical, collagen, diaphragmatic hernia1 recall0 reports
- XENMATRIX 1161015Davol Inc. · Mesh, surgical, collagen, diaphragmatic hernia13 reports
- XENMATRIX 1161928Davol Inc. · Mesh, surgical, collagen, diaphragmatic hernia9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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