XENMATRIX 1162020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741031458), received between Sep 17, 2026 and Sep 17, 2026 — 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.

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.

• DeathSep 17, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2005 - Patient was diagnosed with ventral hernia thereby underwent open repair with implant of Composix Kugel Patch (Device 1). Per operative notes, "An incision was made into the midline of the umbilicus. The hernia sac was dissected out. A large Composix Kugel Patch (Device 1) was placed into the preperitoneal cavity and secured it with sutures."(b)(6)2013 - Patient was diagnosed with adhesion, thereby underwent open repair with explant of Composix Kugel Patch (Device 1) and primary hernia repair. Per operative notes, "A midline incision was made into the abdomen. The old mesh (Device 1) was removed from abdominal wall. Multiple adhesions to the anterior abdominal wall were carefully lysed from both sides of the anterior abdominal wall. The defect was closed with sutures primarily."(b)(6)2014 - Patient was diagnosed with abdominal wall infection, ventral hernia, necrosis, abscess, purulent discharge thereby underwent open repair with implant of XenMatrix Graft (Device 2). Per operative notes, "An incision was made around the previous infected skin. There were necrotic tissues present into the abdominal cavity. The hernia sac was dissected out. Into

  Patient problems: Adhesion(s); Erosion; Fistula; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 50798277 ↗