XENMATRIX 1152020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741074295), received between Apr 20, 2017 and Jul 27, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Patient-Device Incompatibility

  As per patient advocate:NI/NI/NI - The patient had a small bowel obstruction and underwent surgery which included creation of an ileostomy.On (b)(6) 2021- The patient underwent an Ileostomy Reversal and Abd Wall Reconstruction procedure with implant of a XenMatrix AB Graft (device #1). Post implant the patient experienced wound healing issues, seromas, infections and was treated with wound care and antibiotics.On (b)(6) 2022- The patient was diagnosed with a Ventral Hernia and underwent repair with implant of the Phasix Mesh (device #2).On (b)(6) 2022 - The patient was diagnosed with an Incarcerated Incisional Hernia and underwent repair with the implant of a Soft Mesh (device #3). As reported, the patient has not had any of the meshes removed. As reported, patient experienced multiple post operative complications including wound healing issues and chronic abdominal pain. Patient has had multiple epidural injections and had a pain stimulator with no relief. Reportedly, the patient is currently experiencing "inflammation in her gut and swelling in her left leg." Patient has seen at least 4 different gastroenterologists for her gastrointestinal issues, had been diagnosed with a pancr

  Patient problems: Abdominal Pain; Impaired Healing; Seroma; Unspecified Infection

  MAUDE report 50021379 ↗
• InjuryJun 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING IS ASSOCIATED TO A PATIENT WHO IS PART OF A CLINICAL STUDY. ON (B)(6) 2016 - THE PATIENT UNDERWENT AN INTRAPERITONEAL REPAIR WITH COMPONENT SEPARATION TECHNIQUE TO REPAIR THE HERNIA (SUBXIPHOID) USING A XENMATRIX AB GRAFT. AS NOTED THE WOUND SITE WAS CONTAMINATED WITH A BACTERIAL WOUND INFECTION (ECOLI) PRIOR TO IMPLANT OF THE STUDY DEVICE. EXPLANT OF A PREVIOUSLY PLACE NON DAVOL PARIETEX MESH WAS PERFORMED AT THIS TIME. A FISTULA IS NOTED TO HAVE BEEN PRESENT AT THE TIME OF THE PROCEDURE AND THE MIDLINE FASCIA WAS NOT CLOSED AT THIS TIME DUE TO NECROTIC TISSUE AROUND HERNIA DEFECT. A VACUUM ASSISTED CLOSURE WAS PERFORMED. IT IS NOTED IS THAT A 5CM OVERLAP OF THE DEFECT WITH THE GRAFT WAS NOT MAINTAINED AND ONLY A 2CM OVERLAP WAS MAINTAINED DUE TO NECROTIC TISSUE AROUND THE HERNIA DEFECT. THE WOUND NEVER INITIALLY HEALED POSTOPERATIVELY AND WAS ASSESSED BY THE CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. ON (B)(6) 2016 - (B)(6) 2017 - THE PATIENT WAS DIAGNOSED AND TREATED FOR, C-DIFF TOXIN, UTI, KLEBSIELLA BACTERIA, UTI WITH BACTERIA WITH ECOLI, AND VRE INFECTED ABDOMINOPELVIC HEMATOMA. THESE DIAGNOSIS HAVE BEEN ASSESSED BY

  Patient problems: Hernia; Impaired Healing; Unspecified Infection

  MAUDE report 7638452 ↗
• InjuryJan 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A POST OPERATIVE SEROMA AND WOUND DEHISCENCE. ON (B)(6) 2016 - THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH VENTRAL HERNIA REPAIR WITH IMPLANT OF BARD/DAVOL VENTRALIGHT ST HERNIA PATCH (THIS PROCEDURE WAS PRIOR TO THE (B)(6) CLINICAL STUDY.) ON (B)(6) 2016 - THE PATIENT UNDERWENT SURGERY FOR INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS DUE TO SURGICAL SITE INFECTION/ABSCESS. ON (B)(6) 2017 - THE PATIENT WAS IMPLANTED WITH THE XENMATRIX AB GRAFT DURING A HERNIA REPAIR PROCEDURE. THE HERNIA SITE CLASSIFICATION IS NOTED AS A CLASS III (CONTAMINATED). AN INTRAPERITONEAL WITHOUT COMPONENT SEPARATION TECHNIQUE WAS PERFORMED. THE DEFECT MEASURED 12 CM IN LENGTH AND 8 CM IN WIDTH. THE GRAFT WAS TRIMMED AND A 5 CM GRAFT OVERLAP WAS MAINTAINED AROUND THE HERNIA DEFECT. THIS WAS A MIDLINE HERNIA LOCATED IN THE UMBILICAL AND INFRAUMBILICAL AREA. A LONG-TERM ABSORBABLE MONOFILAMENT SUTURE WAS USED WITH 15 FIXATION POINTS. THE PREVIOUSLY IMPLANTED BARD VENTRALIGHT ST HERNIA PATCH WAS EXPLANTED DURING THIS PROCEDURE. TWO DRAINS WERE INSERTED IN THE LEFT LOWER QUADRANT AND ONE IN THE RIGHT LOWER QUADRANT. O

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 7216409 ↗
• InjuryApr 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED AND IS PART OF A XENMATRIX AB CLINICAL STUDY. AS INITIALLY REPORTED - (B)(6) 2017. IN 03/2017 THE PATIENT WAS IMPLANTED WITH A XENMATRIX AB GRAFT. THE PATIENT PRESENTED TO THE CLINIC FOR HER ONE MONTH FOLLOW UP VISIT ON (B)(6) 2017. SHE PRESENTED WITH AN INTERMITTENT FEVER AND FECULENT AND PURULENT SECRETIONS FROM THE INFERIOR POLE OF HER MIDLINE INCISION AND FROM HER JP DRAINS. SHE WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH AN ABDOMINAL ABSCESS AND FISTULA. PATIENT UNDERWENT CT GUIDED DRAINAGE OF THE FLUID COLLECTION. APPROXIMATELY 10CC OF SANGUINEOUS (BLOODY) FLUID WAS OBTAINED. ABDOMINAL WOUND CULTURED AND REVEALED BACTERIAL GROWTH. THE ABSCESS AND FISTULA ARE BOTH ASSESSED AS DEFINITELY RELATED TO THE DEVICE AND TO THE PROCEDURE. THE PATIENT¿S OUTCOME IS CURRENTLY LISTED AS RECOVERING AND RESOLVING. ADDENDUM: SUPPLEMENTAL #1 - (B)(6) 2017 (B)(6) 2017 - THE PATIENT PRESENTED WITH SOFT, NON TENDER, SEROSANGUINEOUS OUTPUT FROM RIGHT LOWER QUADRANT OPENING, MURKY OUTPUT FROM 2 X 2 LOWER ABDOMINAL OPENING AND 0.5 CM OPENING IN THE MIDLINE SUPERIOR TO LARGER OPENINGS WITH SIMILAR DRAINAGE. (B)(6) 2017 - THE PATIENT WAS ADMITTED TO THE HOSPITAL AND RECE

  Patient problems: Abscess; Bacterial Infection; Fistula

  MAUDE report 6507792 ↗