XENMATRIX 1161520Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741031410), received between Apr 6, 2022 and Feb 27, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL INCISIONAL HERNIA WITH BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE THROUGH THE OLD SCAR. THERE WERE MULTIPLE HERNIA DEFECTS. HERNIA SAC WERE TAKEN DOWN. A SEPRAMESH IP (DEVICE 1) WAS PLACED INTO THE DEFECT AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INFECTED MESH, ABDOMINAL WALL ABSCESS, WITH FISTULA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE 1) AND LAPAROTOMY, PLACEMENT OF WOUND VAC. PER OPERATIVE NOTES, ¿A VERTICAL MIDLINE INCISION WAS MADE JUST BELOW THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. FISTULA WAS REMOVED FROM BELOW THE UMBILICUS. THERE WERE DENSE NUMBER OF ABSCESSES INTO THE ABDOMINAL WALL, WHICH WERE DRAINED. THE CHRONICALLY INFECTED PREVIOUSLY PLACED MESH WAS EXCISED PARTIALLY. THE WOUND WAS IRRIGATED AND VAC PLACEMENT WAS DONE.¿ ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCARCERATED VENTRAL/INCISIONAL HERNIA, ADHESIONS, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX SURGICAL GRAFT (DEVICE 2) AND EXPLANT OF SEPRAME

  Patient problems: Abscess; Purulent Discharge

  MAUDE report 24466403 ↗
• InjuryAug 27, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMINAL WALL USING PROLENE SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF XENMATRIX (DEVICE 2). PER OP NOTES, "A MIDLINE INCISION WAS MADE. ADHESIOLYSIS WAS PERFORMED, THE OLD MESH (DEVICE 1) WAS EXCISED. A XENMATRIX (DEVICE 2) WAS PLACED INTO RECTRO RECTUS SPACE USING PROLENE SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3). PER OP NOTES, "THE PREVIOUSLY PLACED BIOLOGIC MESH (DEVICE 2) HAD TORN IN HALF AND RETRACTED. DENSE ADHESIONS TO THE MESH WERE CLEARED. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED ABOVE THE LEVEL OF THE BIOLOGIC MESH (DEVICE 2) AND BELOW HE PERITONEUM." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH USING EC

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22901737 ↗
• InjuryNov 13, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCISIONAL UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS COMPLETELY DISSECTED. A VENTRALEX MESH WAS PLACED IN THE PERITONEAL CAVITY AND SECURED CIRCUMFERENTIALLY WITH SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE OLD VENTRALEX MESH WAS REMOVED IN ITS ENTIRETY. THERE WAS A RECURRENT UMBILICAL HERNIA DEFECT, ELECTED TO REPAIR THIS PRIMARILY. THE FASCIA SEPRAFILM WAS PLACED OVER THE ABDOMINAL CONTENTS AND SUTURED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH FASCIAL DEHISCENCE THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF XENMATRIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE DEFECT AT THE PERIUMBILICAL REGION WAS TOO LARGE AND THEREFORE PLACED A XENMATRIX BIOLOGIC MESH IN AN UNDERLAY FASHION AND TACKED CIRCUMFERENTIALLY WITH SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS THEREBY UNDERWENT DRAINAGE OF ABDOMINAL WALL ABSCESS. (B)(6) 2015 - PATIENT WAS DIAGNOSED WIT

  Patient problems: Abscess; Adhesion(s); Fistula; Hematoma; Hernia; Inflammation; Unspecified Infection

  MAUDE report 20671922 ↗
• InjuryMay 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A XENMATRIX (DEVICE #1) AND VENTRALIGHT ST (DEVICE #2). CASE-SPECIFIC DETAILS NOT PROVIDED. THIS FILE REPRESENTS DEVICE #1 (XENMATRIX). ADDENDUM PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2015 - PATIENT WITH COMPLEX MEDICAL/SURGICAL HISTORY WAS DIAGNOSED WITH MULTIPLE INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX MESH (DEVICE #1). PER OPERATIVE NOTE, "OLD MESH AND ADHESIONS WERE TAKEN DOWN. ENTEROTOMY WAS PERFORMED AND A XENMATRIX MESH WAS TRIMMED TO REPAIR SMALL DEFECT. FURTHER, MESH WAS TRIMMED, USED TO BRIDGE MAIN DEFECT AND SUTURED IN PLACE." (B)(6) 2015 - DURING VISITS DUE TO NATIVE ABDOMINAL WALL OF COMPLEX SURGERIES PATIENT HAD THE WOUND DEHISCED POST OPERATIVELY LEAVING THE MESH EXPOSED THEREBY WOUND REOPENED, REMOVED RESIDUAL OLD SYNTHETIC MESH PIECES, AND CLOSED THE DEFECT WITH THE BRIDGING BIOLOGICAL XENMATRIX MESH (DEVICE #1). (B)(6) 2016 - DURING MULTIPLE VISITS PATIENT HAD THE WOUND DEHISCED, PAIN, RECURRENT HERNIAS WHICH WAS L

  Patient problems: Adhesion(s); Bowel Perforation; Hernia; Insufficient Information; Wound Dehiscence

  MAUDE report 19229102 ↗
• InjuryApr 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A COLOSTOMY REVERSAL PROCEDURE ON (B)(6) 2021, A BARD/DAVOL XENMATRIX GRAFT (PORCINE) WAS IMPLANTED IN THE PATIENT. IT WAS REPORTED THAT ONE MONTH POST IMPLANT, ON (B)(6) 2022, THE PATIENT PRESENTED WITH A PUS POCKET BEHIND THE GRAFT. AS REPORTED, THE POCKET WAS CULTURED, IT WAS STERILE PUS AND THE GRAFT WAS EXPLANTED. AS REPORTED, THE SURGEON INDICATED THAT THE PATIENT DID NOT HAVE ANY INFECTION SINCE THE CULTURE WAS NEGATIVE. AS REPORTED, THE SURGEON FELT THAT THE PATIENT HAD SOME TYPE OF REACTION TO THE XENMATRIX GRAFT (PORCINE).

  Patient problems: Hypersensitivity/Allergic reaction; Purulent Discharge

  MAUDE report 14025846 ↗