XENMATRIX 1151935Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741074301), received between Jul 27, 2017 and Jul 30, 2020 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH AND XENMATRIX ON (B)(6) 2012 AND/OR (B)(6) 2016 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 10343301 ↗
• InjuryJul 30, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH AND XENMATRIX ON (B)(6) 2012 AND/OR (B)(6) 2016 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 10343250 ↗
• InjuryJul 15, 2020Material Disintegration; Material Disintegration

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH XENMATRIX AB ON (B)(6) 2020. ONE WEEK POST-IMPLANT, XENMATRIX AB HAD BROKE DOWN AND THE PATIENT WAS TAKEN BACK TO SURGERY.

  Patient problems: Injury

  MAUDE report 10276882 ↗
• InjuryJun 18, 2019Material Disintegration; Material Disintegration

  AS REPORTED THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2019 AND WAS IMPLANTED WITH A BARD/DAVOL XENMATRIX AB GRAFT. SURGEON REPORTS "THIS WAS A WORSE OF THE WORSE CASE AND CLEARLY CONTAMINATED." THE ABDOMEN WAS LEFT OPEN. AS REPORTED THE PATIENT WAS TAKEN BACK INTO SURGERY TWO DAYS LATER AND THE SURGEON NOTED 30% OF THE GRAFT WAS COMPLETELY BROKEN DOWN AND NON EXISTENT. THE SURGEON DID NOT EXPECT THE GRAFT TO HAVE BROKEN DOWN TO THIS EXTENT AFTER TWO DAYS.

  Patient problems: No Code Available

  MAUDE report 8709644 ↗
• InjuryApr 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY HAD EXPERIENCED POSTOPERATIVE PAIN. ON (B)(6) 2016 THE SUBJECT PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, EXCISION OF SUTURE GRANULOMATA WITH IMPLANT OF A XENMATRIX AB GRAFT. AT THE TIME OF THE PROCEDURE, THE PATIENT HAD A BACTERIAL INFECTION OF THE WOUND IN WHICH CULTURES REVEALED STAPHYLOCOCCUS AUREUS. THE PROCEDURE WAS NOT DELAYED FOR TREATMENT. A RECTO-RECTUS WITH COMPONENT SEPARATION TECHNIQUE WAS PERFORMED USING AN OPEN METHOD FOR CST. THE XENMATRIX AB WAS TRIMMED AND A 5CM GRAFT OVERLAP WAS MAINTAINED AROUND THE HERNIA DEFECT. THE HERNIA WAS LOCATED IN THE EPIGASTRIC AREA WITH SUTURE FIXATION OF THE GRAFT. THE MIDLINE FASCIA AND SKIN WERE COMPLETELY CLOSED. DRAINS WERE INSERTED IN THE RIGHT LOWER QUADRANT AND THE LEFT LOWER QUADRANT. ON (B)(6) 2016 THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2017 SUBJECT PATIENT PRESENTED WITH "INTERMITTENT STABBING, POSTOPERATIVE PAIN IN THE RIGHT SIDE NEAR INCISION." THE RIGHT LOWER QUADRANT DRAIN WAS REMOVED DURING THIS VISIT. ON (B)(6) 2017 THE LEFT LOWER QUADRANT DRAIN WAS REMOVED. THE AE IS INDICATED AS RESOLVED ON (B)(6) 2017. THIS

  Patient problems: Pain

  MAUDE report 7446173 ↗
• InjuryFeb 15, 2018Material Disintegration; Material Disintegration

  IT IS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A "WOUND CLOSURE WITH MESH BRIDGE" USING A XENMATRIX AB GRAFT. AS REPORTED, THE FOLLOWING DAY THE PATIENT'S WOUND DEHISCED AND ALLEGEDLY THE XENMATRIX AB GRAFT WAS COMPLETELY DISSOLVED. AS REPORTED, THE XENMATRIX AB GRAFT WAS NOT IMPLANTED INTO AN INFECTED WOUND.

  Patient problems: Wound Dehiscence

  MAUDE report 7272637 ↗
• InjuryFeb 7, 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. ON (B)(6) 2002- THE PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR. (DETAILS NOT PROVIDED) ON (B)(6) 2016 - THE PATIENT UNDERWENT BILATERAL BREAST RECONSTRUCTION. ON (B)(6) 2016 - THE PATIENT UNDERWENT PARTIAL REMOVAL OF INFECTED MESH (UNKNOWN) AND HERNIA REPAIR. ON (B)(6) 2017- THE PATIENT UNDERWENT ADDITIONAL REMOVAL OF INFECTED MESH (UNKNOWN) WITH INCISIONAL HERNIA REPAIR. DURING THIS PROCEDURE A BARD/DAVOL FLAT MESH WAS IMPLANTED TO REPAIR AN INCISIONAL HERNIA. THE HERNIA SITE WOUND WAS CLASSIFIED AS CLASS III CONTAMINATED. ON (B)(6) 2017 - THE PATIENT UNDERWENT ABDOMINAL WOUND DEBRIDMENT AND LOCAL TISSUE REARRANGING. ON (B)(6) 2017- THE PATIENT UNDERWENT IMPLANT OF THE XENMATRIX AB GRAFT FOR HERNIA REPAIR. THE HERNIA SITE CLASSIFICATION IS NOTED AS A CLASS III CONTAMINATED. AN INTRAPERITONEAL WITH COMPONENT SEPARATION TECHNIQUE WAS PERFORMED IN OPEN FASHION. THE DEFECT MEASURED 15CM IN LENGTH AND 22CM IN WIDTH. THE XENMATRIX AB GRAFT WAS TRIMMED AND A 5CM OVERLAP WAS MAINTAINED AROUND THE HERNIA DEFECT. THIS WAS A MIDLINE HERNIA LOCATED IN THE UMBILICAL, INFRAUMBILICAL AN

  Patient problems: Hernia; Seroma

  MAUDE report 7249599 ↗
• InjuryJan 30, 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 INFECTED SEROMA. ON (B)(6) 2002 - THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL KUGEL MESH FOR THE REPAIR OF A RECURRENT MIDLINE HERNIA. ON (B)(6) 2017 - THE PATIENT UNDERWENT THE IMPLANT OF A XENMATRIX AB GRAFT AND COLON RESECTION, DURING THIS PROCEDURE A PREVIOUSLY PLACED "KUGEL" MESH WAS EXPLANTED. THE HERNIA SITE WOUND CLASSIFICATION IS LISTED AS BEING A CLASS IV (DIRTY-INFECTED). THE PATIENT IS NOTED TO HAVE A BACTERIAL INFECTION WITH (B)(6), ESCHERICHIA COLI, ENTEROCOCCUS AVIUM, AND BACTEROIDES FRAGILIS. AN INTRAPERITONEAL WITH COMPONENT SEPARATION TECHNIQUE WAS USED. THE PROCEDURE WAS PERFORMED IN OPEN FASHION AND A FISTULA IS NOTED TO HAVE BEEN PRESENT AT THE TIME OF SURGERY. THE SIZE OF THE HERNIA DEFECT WAS 30CM IN LENGTH AND 13CM IN WIDTH. THE XENMATRIX AB GRAFT WAS TRIMMED AND A 5CM OVERLAP WAS MAINTAINED AROUND THE HERNIA DEFECT. THE HERNIA WAS LOCATED IN THE MIDLINE ABDOMEN AND INVOLVED THE SUBXIPHOID, EPIGASTRIC, UMBILICAL, INFRAUMBILICAL AND SUPRAPUBIC AREAS. THE MESH WAS SUTURED WITH LONG-TERM ABSORBABLE MONOFILAMENT SUTURES USING 31 FIXATION POINTS. THE MIDLINE FASCI

  Patient problems: Bacterial Infection; Pain; Seroma

  MAUDE report 7229085 ↗
• InjuryJan 29, 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. ON (B)(6) 2017 - THE PATIENT UNDERWENT IMPLANT OF THE XENMATRIX AB GRAFT DURING A COMPLEX MULTI-PART PROCEDURE INCLUDING A COLECTOMY, END ILEOSTOMY, SPLENIC FLEXURE MOBILIZATION, SUBTOTAL GASTRECTOMY, AND GASTROCOLIC TAKEDOWN. THE PROCEDURE WAS PERFORMED INTRAPERITONEAL WITH COMPONENT SEPARATION TECHNIQUE. A FISTULA IS NOTED TO HAVE BEEN PRESENT AT THE TIME OF THIS PROCEDURE. THE SIZE OF THE HERNIA DEFECT WAS 30CM IN LENGTH AND 15CM 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 SUBXIPHOID, EPIGASTRIC, UMBILICAL, INFRAUMBILICAL AND SUPRAPUBIC SPACE. THE PERIMETER OF THE MESH WAS SUTURED WITH LONG-TERM ABSORBABLE MONOFILAMENT WITH 33 FIXATION POINTS. THE MIDLINE FASCIA AND SKIN WERE COMPLETELY CLOSED. A DRAIN WAS INSERTED IN THE LEFT UPPER QUADRANT, THE LEFT LOWER QUADRANT AND THE RIGHT LOWER QUADRANT. HERNIA SITE WOUND CLASSIFICATION NOTED AS CLASS III (CONTAMINATED). THE PATIENT EXPERIENCED ACUTE BLOOD LOSS ANEMIA WHICH WAS ASSESSED

  Patient problems: Pain; Seroma

  MAUDE report 7226342 ↗
• InjuryJul 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CONTACTING SURGEON REPORTED, A POSSIBLE FINDING REGARDING THE XENMATRIX AB MESH AND USE OF MICROCYN IRRIGATION WITH THE VERAFLOW SYSTEM. THE XENMATRIX AB MESH WAS PLACED IN THE SUBLAY FASHION WITH COMPLETE CLOSURE OF THE PATIENT¿S ABDOMINAL FASCIA. THE VERAFLOW SYSTEM AND USE OF XENMATRIX MESH WERE USED TO TREAT PATIENT¿S CHRONIC (B)(6) INFECTION OF THE ABDOMINAL WALL POST EXPLANT OF AN UNSPECIFIED INFECTED MESH. THE SURGEON REPORTS SHE LEFT A JP DRAIN OVER THE SUBLAY MESH WHILE PATIENT HAD THE VERAFLOW IRRIGATION. THE OUTPUT OF THE JP TURNED FROM LIGHT BROWN TO DARK GREEN COLOR. ANOTHER PHYSICIAN INITIALLY THOUGHT THE OUTPUT TO BE SUCCUS ENTERICUS AND CULTURED THE OUTPUT (IT GREW OUT CANDIDA AND A FEW GRAM POSITIVE BACILLI AND MODERATE GRAM POSITIVE COCCI IN CHAINS (LIKELY (B)(6)). SO THIS IS DEFINITELY NOT SUCCUS. THE CONTACTING SURGEON REMOVED THE DRAIN PRIOR TO DISCHARGING PATIENT TO HOME WITH HOME HEALTH WOUND VAC DRESSING CHANGE. PATIENT WAS READMITTED THIS WEEKEND WITH THE HOME HEALTH RN REPORTING SUCCUS MATERIAL SEEN AT THE MIDLINE DURING HER FIRST DRESSING CHANGE. THE SUCCUS WAS NOT SEEN BY THE SURGEON ON CALL WHEN EXAMINING THE PATIENT. THE REPORTING SURGEON THINKS THAT T

  Patient problems: No Code Available

  MAUDE report 6748971 ↗