XENMATRIX 1151525Recalls & reported problems
Davol Inc. · XenMatrix AB Surgical Graft, 15 cm x 25 cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741074257), received between Apr 3, 2025 and Apr 3, 2025 — classified as 1 death.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Abdominal Pain1
- Adhesion(s)1
- Fluid Discharge1
- Hernia1
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PER MEDWATCH REPORT (MW5167617), "ALLEGED EVENT: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 1ST STRATTICE ON (B)(6) 2016 AND 2ND STRATTICE ON (B)(6) 2017. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN REMOVED OR REVISED. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION. PATIENT HAS DIED ON (B)(6) 2022 AND THERAILS OE IS NO FURTHER DETN DEATH CAUSALITY. THIS RECORD CAPTURED 1ST STRATTICE. ON (B)(6) 2025, (B)(6) RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT WAS BORN WITH AN ABDOMINAL WALL DEFECT (GASTROSCHISIS), WHO UNDERWENT A VENTRAL HERNIA SURGERY AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT SP100381-101 ON (B)(6) 2016. THE PATIENT UNDERWENT AN OPEN VENTRAL INCISIONAL HERNIA REPAIR WITH BIOLOGICAL MESH ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH A SECOND STRATTICE DEVICE LOT SP100537-078 ON THE SAME DATE. THE PATIENT THEN UNDERWENT AN INCISIONAL/VENTRAL HERNIA REPAIR WITH BIOLOGIC MESH ON (B)(6) 2018 AND IMPLANTED WITH A THIRD STRATTICE DEVI
Patient problems: Abdominal Pain; Adhesion(s); Fluid Discharge; Hernia; Obstruction/Occlusion
MAUDE report 21761314 ↗
Other Mesh, surgical devices
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- Supple Peri-Guard SPG0404Synovis Life Technologies, Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-403-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-006Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-019Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-001-009Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-004-105Tei Biosciences Inc. · Mesh, surgical1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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