XENMATRIX 1162025Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741031465), received between May 15, 2018 and Nov 2, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2022Expiration Date Error; Expiration Date Error

  AS REPORTED ON (B)(6) 2022 WHILE PERFORMING THE COMPLEX ABDOMINAL WALL REPAIR, A XENMATRIX SURGICAL GRAFT WAS IMPLANTED WITH A LABELED EXPIRATION DATE OF (B)(6) 2022. AS REPORTED, THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION PERFORMED. THE STERILE PACKAGING WAS INTACT PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY, THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714255 ↗
• InjuryOct 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL(B)(4): ON (B)(6) 2014, THE PATIENT UNDERWENT FIRST TIME RECURRENT INCISIONAL MIDLINE OPEN HERNIA (20 CM X 8 CM) REPAIR PROCEDURE, DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY USING ANTERIOR COMPONENT SEPARATION TECHNIQUE (CST) METHOD, FIXATED USING NON-BARD/DAVOL MAXON SUTURE. FASCIA WAS ACHIEVED USING NON-BARD/DAVOL VICRYL INTERRUPTED STITCH AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. CONCOMITANT PROCEDURE INCLUDES PANNICULECTOMY, LYSIS OF ADHESIONS AND BOWEL RESECTION. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH INCISIONAL MIDLINE HERNIA RECURRENCE (1CM X 7CM) AND CONFIRMED THROUGH CT SCAN WHICH WAS PERFORMED ON SAME DAY. AS REPORTED, THE PATIENT UNDERWENT OPEN MIDLINE INCISIONAL HERNIA RECURRENCE REPAIR PROCEDURE ON (B)(6) 2022 WITH THE IMPLANT OF UNKNOWN ABSORBABLE SYNTHETIC MESH AND PLACED IN ONLAY FASHION. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2022. THE AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY TO THE PROCEDURE. THIS HAS BEEN ASSESSED AS A SERIOUS ADVERSE EVENT OF MODERATE SEVERITY. T

  Patient problems: Hernia

  MAUDE report 15536184 ↗
• InjuryAug 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2015, THE SUBJECT PATIENT UNDERWENT FIRST TIME RECURRENT INCISIONAL SUPRAPUBIC OPEN HERNIA REPAIR PROCEDURE, DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN SUBLAY FASHION, FIXATED USING VICRYL SUTURES WITH INTERRUPTED STITCH TECHNIQUE. THE FASCIA CLOSURE AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. CONCOMITANT PROCEDURES INCLUDE PANNICULECTOMY, LYSIS OF ADHESION(S). ON (B)(6) 2015, THE SUBJECT PATIENT WAS DIAGNOSED WITH WOUND DEHISCENCE. THE PATIENT UNDERWENT CT SCAN WHICH SHOWS NO HERNIA RECURRENCE/FLUID COLLECTIONS AND THE AE WAS RESOLVED ON (B)(6)2016. THE AE IS CLINICALLY ASSESSED TO BE OF MILD SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT).

  Patient problems: Wound Dehiscence

  MAUDE report 15294320 ↗
• InjuryAug 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2014, THE PATIENT UNDERWENT PRIMARY VENTRAL MIDLINE OPEN HERNIA REPAIR PROCEDURE, DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY AND FIXATED USING SUTURES. FASCIA WAS ACHIEVED USING INTERRUPTED SUTURES AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. CONCOMITANT PROCEDURE INCLUDES ILEOSTOMY CLOSURE AND CREATION OF A COLOSTOMY. ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH REDUCIBLE PARASTOMAL HERNIA RECURRENCE AT RIGHT UPPER QUADRANT (RUQ). THE AE IS CLINICALLY ASSESSED TO BE OF MILD SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE AND RECOVERING/RESOLVING. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT).

  Patient problems: Hernia

  MAUDE report 15181883 ↗
• InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2014, THE PATIENT UNDERWENT FIRST TIME RECURRENT INCISIONAL MIDLINE OPEN HERNIA (20 CM X 8 CM) REPAIR PROCEDURE, DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN INLAY FASHION INTRA-PERITONEALLY USING ANTERIOR COMPONENT SEPARATION TECHNIQUE (CST) METHOD, FIXATED USING SUTURES. FASCIA WAS ACHIEVED USING VICRYL INTERRUPTED SUTURES AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. CONCOMITANT PROCEDURE INCLUDES PANNICULECTOMY, LYSIS OF ADHESIONS AND BOWEL RESECTION. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH AN ABSCESS AND WAS ADMITTED INTO THE HOSPITAL. THE PATIENT WAS DISCHARGED THE NEXT DAY ON (B)(6) 2015. THE ADVERSE EVENT WAS RESOLVED ON (B)(6) 2015. THE AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. THIS HAS BEEN ASSESSED AS A SERIOUS ADVERSE EVENT OF MODERATE SEVERITY. THE REPORTED ADVERSE EVENT MEETS THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNIDENTIFIED ADVERSE DEVICE EVENT).

  Patient problems: Abscess

  MAUDE report 15151137 ↗
• InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2014, THE SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT OPEN INCISIONAL TRANSVERSE HERNIA REPAIR, DURING WHICH TWO XENMATRIX SURGICAL GRAFTS WERE TRIMMED AND PLACED IN UNDERLAY FASHION ON THE INTRA-PERITONEAL REGION USING A SUTURE. FASCIA WAS COMPLETELY CLOSED WITH VICRYL SUTURE IN INTERRUPTED STITCH TECHNIQUE AND FULL CLOSURE WAS ACHIEVED WITH SUTURES. CONCOMITANT PROCEDURE ABDOMINAL WASH OUT WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH AN ABSCESS AND WAS ADMITTED INTO THE HOSPITAL. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH AN ENTEROCUTANEOUS FISTULA AND WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2015. DURING THIS HOSPITAL STAY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE (DETAILS NOT PROVIDED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. THE AE, ABSCESS IS CLINICALLY ASSESSED TO BE NOT RELATED TO THE PROCEDURE AND DEFINITELY RELATED TO THE STUDY DEVICE. THIS AE, ENTEROCUTANEOUS FISTULA IS CLINICALLY ASSESSED TO BE NOT RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE STUDY DEVICE. THESE A

  Patient problems: Abscess; Fistula

  MAUDE report 15151071 ↗
• InjuryMay 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PHYSICIAN (NOT IMPLANTING PHYSICIAN) REPORTED THAT A PATIENT WHO HAD BEEN IMPLANTED WITH A DAVOL XENMATRIX GRAFT ON (B)(6) 2013 CAME TO HIS OFFICE REQUESTING THAT THE HERNIA GRAFT BE REMOVED. WHEN INITIALLY PLACED THE GRAFT WHICH HAD BEEN SIZED FROM 20X25 TO A 16X20 PRIOR TO IMPLANT WAS PLACED INTO THE RETRO RECTUS TISSUE PLAIN IN AN OPEN PROCEDURE. AS REPORTED 6 TO 12 MONTHS POST IMPLANT THE PATIENT'S SYMPTOMS (RED SKIN / REACTION) BEGAN. THE PHYSICIAN REPORTS THAT HE REVIEWED HER CT IMAGES AND THE MESH WAS FULLY INCORPORATED AND THERE APPEARED TO BE NO FLUID COLLECTION. THE PHYSICIAN REPORTS THAT HE IS UNCOMFORTABLE WITH SURGICALLY TRYING TO REMOVE THE MESH BECAUSE HE IS NOT CONFIDENT THE MESH IS THE ROOT CAUSE OF HER SYMPTOMS AND BECAUSE HE BELIEVES THE GRAFT WOULD BE FULLY INCORPORATED INTO HER TISSUE AND HAS LIKELY BEEN FULLY RESORBED. HE SAID THAT HE DOES NOT BELIEVE THE PATIENT'S SYMPTOMS ARE RELATED TO THE GRAFT. THE PHYSICIAN REPORTS THAT HE BELIEVES IT MAY BE ERYTHEMA AB IGNE OR SOME SORT OF ¿IMMUNE, VASCULITIS OR ENDOCRINE PROBLEM¿. HE IS ALSO CONSIDERING REFERRING HER TO A DERMATOLOGIST OR RHEUMATOLOGIST.

  Patient problems: Reaction

  MAUDE report 7515729 ↗