XENMATRIX 1151928Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741074271), received between Apr 5, 2017 and Jan 8, 2026 — classified as 1 death, 4 injuries.

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

• InjuryJan 8, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2000- PATIENT WAS DIAGNOSED WITH GIANT VENTRAL INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA WAS IDENTIFIED IN RIGHT UPPER QUADRANT. A BARD FLAT MESH WAS ATTACHED TO FASCIA OF LEFT UPPER QUADRANT AND RIGHT UPPER QUADRANT AND SUTURED¿. (B)(6) 2002- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE BARD FLAT MESH (DEVICE 1) WAS IDENTIFIED TO BE LOOSEN FROM THE LATERAL ABDOMINAL WALL. A HERNIA WITH OMENTUM WAS IDENTIFIED IN THE RIGHT LATERAL ABDOMINAL REGION. THE BARD FLAT MESH (DEVICE 1) WAS SUTURED TO THE LATERAL ABDOMINAL WALL¿. (NOTE: THERE IS NO INDICATION IN THE MEDICAL RECORDS PROVIDED THAT THE PATIENT WAS IMPLANTED WITH A BARD FLAT MESH (DEVICE 2) DURING THIS REPAIR) (B)(6) 2019- PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA, THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE SMALL INTESTINE WAS ADHERENT TO PREVIOUSLY PLACED MESH OF THE ABDOMINAL WALL, WHICH RESULTED IN THE ENTEROCUTANEOUS FISTULA. SEVERE ADHESIONS WERE ALSO NOTED WITH THE BARD FLAT MESH AND WAS LYSED.

  Patient problems: Abscess; Pain; Purulent Discharge

  MAUDE report 24002476 ↗
• DeathApr 9, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF THE COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS EXCISED. LYSIS OF ADHESIONS WAS PERFORMED, AND A LARGE PIECE OF COMPOSIX KUGEL MESH (DEVICE #1) WAS PLACED AND TACKED UNDERSURFACE OF PERITONEUM CIRCUMFERENTIALLY.¿ (B)(6) -2007 TO (B)(6) 2010 - PATIENT HAD ABDOMINAL PAIN. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS SECONDARY TO BOWEL FISTULA WITH MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF OLD MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE MESH (DEVICE #1) WAS DISSECTED CIRCUMFERENTIALLY FROM THE ABDOMINAL WALL. FISTULA WAS FOUND IN THE SMALL BOWEL WHERE THERE WAS FRANK BILE STAINED MESH ON THE LEFT LATERAL ASPECT AND CAREFULLY DISSECTED THIS BOWEL. LYSIS OF ADHESIONS WAS PERFORMED THAT WAS INTIMATELY INVOLVED WITH MESH AND THEN RE-ANASTOMOSIS.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH PAIN, LONG STANDING ABDOMINAL WALL MESH ABSCESS THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF XENMATIX AB GRAFT (DEVICE #2) AND PHASIX MESH (DEVICE #3). PER OPERATIVE NOTES, ¿LYSIS OF A

  Patient problems: Bowel Perforation; Cellulitis; Fasciitis; Fistula; Inflammation; Peritonitis

  MAUDE report 19072583 ↗
• InjuryJul 1, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2010, VENTRALEX ST AND VENTRIO ST ON (B)(6) 2014, PHASIX MESH AND XENMATRIX AB ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2016. ATTORNEY 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿THE LIPOMA OF THE CORD WAS EXCISED. A SEPRAMESH IP (DEVICE #1) WAS PLACED AND SECURED TO THE FASCIA USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT COMPLEX VENTRAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE #1) AND IMPLANT

  Patient problems: Abdominal Pain; Abscess; Insufficient Information; Pain

  MAUDE report 12097828 ↗
• InjuryApr 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY IS EXPERIENCING MILD POSTOPERATIVE PAIN. ON (B)(6) 2016 - THE PATIENT UNDERWENT IMPLANT OF THE XENMATRIX AB MESH, DURING A COMPLEX MULTI-PART PROCEDURE INCLUDING LYSIS OF ADHESIONS TO REMOVE BOWEL OBSTRUCTION, EXCISION OF MASS, REMOVAL OF AN UNKNOWN SYNTHETIC PREVIOUSLY PLACED MESH AND DEBRIDEMENT. THE PROCEDURE WAS PERFORMED RETRO-RECTUS WITHOUT COMPONENT SEPARATION TECHNIQUE. THE SIZE OF THE HERNIA DEFECT WAS 26CM IN LENGTH AND 12CM IN WIDTH. AS REPORTED, IT WAS NECESSARY TO TRIM THE XENMATRIX AB GRAFT AND THERE WAS A 5CM GRAFT OVERLAP MAINTAINED AROUND THE HERNIA DEFECT. THE HERNIA LOCATION WAS MIDLINE AND INVOLVED THE UMBILICAL, SUPRAPUBIC, EPIGASTRIC AND INFRAUMBILICAL SPACE. THE PERIMETER OF THE MESH WAS SUTURED WITH LONG-TERM ABSORBABLE MONOFILAMENT WITH 7 FIXATION POINTS. THE MIDLINE FASCIA AND SKIN WERE COMPLETELY CLOSED. THREE DRAINS WERE INSERTED IN THE RETRO-RECTUS LEFT LOWER QUADRANT, SUBCUTANEOUS RIGHT UPPER QUADRANT AND THE SUBCUTANEOUS LEFT UPPER QUADRANT. ON (B)(6) 2018 - THE PATIENT PRESENT FOR VISIT AND WAS ASYMPTOMATIC. THERE WAS NO EVIDENCE OF HERNIA OR RECURRENCE AND THE PATIENT REPORTED MILD RIGHT

  Patient problems: Pain

  MAUDE report 7397526 ↗
• InjuryApr 5, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED AND IS ASSOCIATED WITH CLINICAL STUDY (B)(4): (B)(6) 2016 - THE PATIENT WAS IMPLANTED WITH A BARD XENMATRIX AB. (B)(6) 2017 - THE PATIENT SEEN FOR A FOLLOW UP VISIT. DURING THIS VISIT, A PREVIOUSLY PERFORMED CT SCAN WAS REVIEWED AND SHOWED A SUPERFICIAL LOWER LEFT ABDOMINAL SEROMA. THE PATIENT WAS SCHEDULED FOR AN OPEN INCISION AND DRAINAGE. THE SEROMA IS ASSESSED AS MILD SEVERITY, GRADE III, POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Seroma

  MAUDE report 6460841 ↗