XENMATRIX 1152540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741129025), received between Sep 9, 2020 and Mar 3, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (X2) ON (B)(6) 2017 AND XENMATRIX AB SURGICAL GRAFT ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2018. ATTORNEY ALSO ALLEGES GENERAL ALLEGATIONS FOR ¿PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16476241 ↗
• InjurySep 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY PRESENTED WITH AN ABDOMINAL BULGE: ON (B)(6) 2017: SUBJECT PATIENT UNDERWENT OPEN SURGERY FOR THE REPAIR OF UMBILICAL, EPIGASTRIC, INFRA UMBILICAL HERNIA MEASURING 20CM X 15CM. SUBJECT PATIENT WAS IMPLANTED WITH XENMATRIX AB SURGICAL GRAFT USING THE RETRO-RECTUS CST/TAR TECHNIQUE. A SWISS CHEESE CONFIGURATION (MULTIPLE DISCREET HERNIAS), WITH CLASS II (CLEAN-CONTAMINATED) WOUND WAS NOTED; WHICH WAS CLEANED OUT PRIOR TO GRAFT PLACEMENT. THE GRAFT WAS TRIMMED TO 25CM X 30CM AND WAS SUTURED IN PLACE USING LONG-TERM ABSORBABLE MULTIFILAMENT SUTURES AT 6 FIXATION POINTS. A MINIMUM OF 5CM OVERLAP WAS ACHIEVED IN ALL DIRECTIONS OF THE INCISION. MIDLINE FASCIA CLOSURE WAS COMPLETED USING LONG-TERM ABSORBABLE SUTURES PLACED 0.8CM APART; SKIN WAS CLOSED USING STAPLES AND 2 DRAINS WERE PLACED IN THE RETRO-RECTUS (RIGHT AND LEFT LOWER QUADRANTS). THE SUBJECT PATIENT WAS ADMINISTERED PROPHYLACTIC ANTIBIOTICS. ON (B)(6) 2017: SUBJECT PATIENT DISCHARGED FROM HOSPITAL. ON (B)(6) 2018: DRAINS WERE REMOVED. ON (B)(6) 2019: SUBJECT PATIENT PRESENTED WITH A GRADE I ABDOMINAL BULGE. THIS ADVERSE EVENT WAS ASSESSED PER THE CLINICIAN

  Patient problems: Hernia

  MAUDE report 10507366 ↗