XENMATRIX 1161015Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741031380), received between May 10, 2018 and Apr 2, 2026 — classified as 8 injuries, 5 malfunctions.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, "AN UPPER ABDOMINAL VENTRAL HERNIA WAS NOTED. THE HERNIA SAC WAS REDUCED ALL THE WAY DOWN TO THE FASCIA AND REMOVED. A LARGE VENTRALEX ST MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SUTURED IN UNDERLAY FASHION WITH SUTURES. THE FASCIAL DEFECT WAS CLOSED AND SECURED WITH SUTURES AND STAPLES." ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH CHRONIC PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX MESH (DEVICE 2) AND REMOVAL OF PRIOR MESH (DEVICE 1). PER OPERATIVE NOTES, THROUGH THE PRIOR INCISION, THE UPPER ABDOMINAL MIDLINE MESH (DEVICE 1) WAS SEEN FIRM AND EXCISED FROM THE SUBCUTANEOUS TISSUES AND OVERLYING SCAR TISSUES. MULTIPLE TITANIUM TACKS WERE ALSO REMOVED. THE RECURRENT FASCIAL DEFECT IN THE MIDLINE IN SUPRAUMBILICAL AREA WAS REMOVED AND FLAPS WERE RAISED. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES. A XENMATRIX MESH (DEVICE 2) WAS PLACED OVER THE FASCIA AND SECURED WITH SUTURES TO THE ANTERIOR ABDOMINAL WALL." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WIT

  Patient problems: Abdominal Pain; Hernia; Scar Tissue

  MAUDE report 24764656 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A VERTICAL INCISION WAS MADE OVER THE SUPRAUMBILICAL MIDLINE OVER THE HERNIA MASS. THE HERNIA SAC WAS REMOVED. A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURE IT WITH SUTURES.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH WOUND INFECTION, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH EXPLORATION AND DEBRIDEMENT OF WOUND. PER OPERATIVE NOTES, ¿A VERTICAL INCISION WAS MADE IN THE UMBILICUS. PREVIOUSLY PLACED MESH WAS WELL INCORPORATED. SCAR TISSUE WAS REMOVED. WOUND WAS IRRIGATED. VAC PLACEMENT WAS DONE FOR WOUND.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA; CHRONIC WOUND INFECTION, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX MESH (DEVICE 1) AND IMPLANT OF XENMATRIX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE PRIOR HERNIA SITE WAS IDENTIFIED IN THE PERIUMBILICAL AREA. THE OLD SCAR WAS IDENTIFIED AND REMOVED ENTIRELY. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED VENTRALEX MESH (DEVICE 1) WAS REMOVED. CHRONIC DRAINAGE WAS DONE FROM THE WOUND. V

  Patient problems: Necrosis; Seroma; Wound Infection

  MAUDE report 23941375 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). (NOTE: THERE IS NO OPERATIVE NOTES FOR THIS PROCEDURE PROVIDED IN MEDICAL RECORD) ON (B)(6) 2006 ¿ PER HOSPITAL COURSE, PATIENT HAD STATUS POST REPAIR OF AN INCARCERATED UMBILICAL HERNIA, WHICH HAS BEEN CAUSING BOWEL OBSTRUCTION. ON (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH FOREIGN BODY, UMBILICAL HERNIA WOUND THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿PATIENT NOTED TO HAVE SOME DRAINAGE COMING FROM THE PERIUMBILICAL SITE. PATIENT WAS ALSO NOTED TO HAVE A CIRCULAR MESH IN THE WOUND. THIS WAS DISSECTED FREE FROM ALL SURROUNDING TISSUES AND WHEN MOBILIZING ON THE LEFT SIDE THERE WAS NOTED TO BE A SMALL BOWEL LOOP WHICH WAS FIRMLY ADHERENT TO THE MESH AND ON FREEING THIS, A SMALL ENTEROTOMY. THIS WAS CLOSED USING SUTURES. THE VENTRALEX MESH (DEVICE 1) WAS COMPLETELY REMOVED.¿ ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX SURGICAL GRAFT (DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA DEFECT AND THE SAC WAS D

  Patient problems: Adhesion(s); Fistula

  MAUDE report 23787640 ↗
• InjuryJun 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCISED. A VENTRALEX MESH (DEVICE #1) WAS PLACED USING SUTURES. ¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE #1) AND IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿A LARGE HERNIA SAC WAS IDENTIFIED, OPENED AND DISSECTED. THE SMALL BOWEL ADHERENT TO HERNIA SAC WERE TAKEN DOWN. THE SMALL BOWEL ALSO ADHERENT TO PRIOR MESH WAS TAKEN DOWN. THE PRIOR MESH WAS EXCISED ALONG WITH HERNIA SAC. A BIOLOGICAL MESH WAS PLACED USING PROLENE SUTURES. ¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF BIOLOGICAL MESH AND IMPLANT OF XENMATRIX (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED, DISSECTED AND OPENED. THE OBSTRUCTED SMALL BOWEL WAS REDUCED BACK TO ABDOMEN. THE HERNIA SAC WAS EXCISED. MULTIPLE ADHESIONS OF OLD MESH WERE LYSED. THE BIOLOGICAL

  Patient problems: Adhesion(s); Scar Tissue

  MAUDE report 22336714 ↗
• MalfunctionMay 19, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, WHEN OPENED FOR A CASE IT WAS NOTED THAT THE INNER STERILE PACKAGE OF THE XENMATRIX GRAFT (DEVICE #1) WAS TORN. AS REPORTED THE PRODUCT BOX WAS COMPLETELY SEALED PRIOR TO OPENING FOR THE CASE. THE DEVICE WAS NOT USED ON THE PATIENT, THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE. AS REPORTED, A QUALITY CHECK WAS COMPLETED AND IDENTIFIED THREE ADDITIONAL XENMATRIX GRAFTS (DEVICE #2, DEVICE #3 AND DEVICE #4) WERE FOUND TO HAVE THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16969766 ↗
• MalfunctionMay 19, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, WHEN OPENED FOR A CASE IT WAS NOTED THAT THE INNER STERILE PACKAGE OF THE XENMATRIX GRAFT (DEVICE #1) WAS TORN. AS REPORTED THE PRODUCT BOX WAS COMPLETELY SEALED PRIOR TO OPENING FOR THE CASE. THE DEVICE WAS NOT USED ON THE PATIENT, THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE. AS REPORTED, A QUALITY CHECK WAS COMPLETED AND IDENTIFIED THREE ADDITIONAL XENMATRIX GRAFTS (DEVICE #2, DEVICE #3 AND DEVICE #4) WERE FOUND TO HAVE THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962635 ↗
• MalfunctionMay 19, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, WHEN OPENED FOR A CASE IT WAS NOTED THAT THE INNER STERILE PACKAGE OF THE XENMATRIX GRAFT (DEVICE #1) WAS TORN. AS REPORTED THE PRODUCT BOX WAS COMPLETELY SEALED PRIOR TO OPENING FOR THE CASE. THE DEVICE WAS NOT USED ON THE PATIENT, THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE. AS REPORTED, A QUALITY CHECK WAS COMPLETED AND IDENTIFIED THREE ADDITIONAL XENMATRIX GRAFTS (DEVICE #2, DEVICE #3 AND DEVICE #4) WERE FOUND TO HAVE THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962605 ↗
• MalfunctionMay 19, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, WHEN OPENED FOR A CASE IT WAS NOTED THAT THE INNER STERILE PACKAGE OF THE XENMATRIX GRAFT (DEVICE #1) WAS TORN. AS REPORTED THE PRODUCT BOX WAS COMPLETELY SEALED PRIOR TO OPENING FOR THE CASE. THE DEVICE WAS NOT USED ON THE PATIENT, THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE. AS REPORTED, A QUALITY CHECK WAS COMPLETED AND IDENTIFIED THREE ADDITIONAL XENMATRIX GRAFTS (DEVICE #2, DEVICE #3 AND DEVICE #4) WERE FOUND TO HAVE THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962601 ↗
• InjurySep 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL STUDY (B)(4): ON (B)(6) 2016, THE SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL MIDLINE OPEN HERNIA REPAIR PROCEDURE, DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION ON THE INTRA-PERITONEAL REGION USING SUTURE (MAXON). FACIA WAS COMPLETELY CLOSED WITH MAXON SUTURE IN INTERRUPTED STITCH TECHNIQUE AND FULL SKIN CLOSURE WAS ACHIEVED WITH SUTURES. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. CONCOMITANT PROCEDURE INCLUDES LYSIS OF ADHESION(S) AND BOWEL RESECTION. ON (B)(6) 2017, THE PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION AND ADMITTED TO HOSPITAL ON (B)(6) 2017 AND IR DRAIN PLACED. INTRA-ABDOMINAL CULTURE WAS PERFORMED, AND THE PATIENT WAS DIAGNOSED WITH (STAPHYLOCOCCUS AUREUS) BACTERIAL INFECTION AND TREATED WITH ORAL ANTIBIOTICS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2017. THE AE IS CLINICALLY ASSESSED TO BE OF MODERATE SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE, DEFINITELY RELATED TO PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED ADVERSE EVENT MEETS THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE UADE (UNANTICIPATED ADVERSE DEVICE EFFECT).

  Patient problems: Bacterial Infection

  MAUDE report 15501118 ↗
• InjurySep 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL STUDY (B)(4): ON (B)(6) 2016, THE SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL MIDLINE OPEN HERNIA REPAIR PROCEDURE, DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION ON THE INTRA-PERITONEAL REGION USING SUTURE (MAXON). FACIA WAS COMPLETELY CLOSED WITH MAXON SUTURE IN INTERRUPTED STITCH TECHNIQUE AND FULL SKIN CLOSURE WAS ACHIEVED WITH SUTURES. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. CONCOMITANT PROCEDURE INCLUDES LYSIS OF ADHESION(S) AND BOWEL RESECTION. ON (B)(6) 2017, THE PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL MIDLINE HERNIA (10CM X 08CM). ON (B)(6) 2018, THE PATIENT UNDERWENT REOPERATION AND WAS IMPLANTED WITH PHASIX ONLAY TO REPAIR THE HERNIA RECURRENCE. THE STUDY MESH WAS NOT REMOVED. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. THE AE IS CLINICALLY ASSESSED TO BE OF MODERATE SEVERITY, POSSIBLE RELATED TO THE DEVICE, NOT RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED ADVERSE EVENT MEETS THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE UADE (UNANTICIPATED ADVERSE DEVICE EFFECT).

  Patient problems: Hernia

  MAUDE report 15500921 ↗
• InjuryApr 2, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT HAD A NUMBER OF ABDOMINAL SURGERIES AND NEEDED THE ABDOMINAL RECTUS MUSCLES REATTACHED AND REPAIRED ON THE LEFT SIDE. AS REPORTED, THE PATIENT UNDERWENT A BILATERAL REINFORCEMENT WITH IMPLANT OF AN UNSPECIFIED BARD/DAVOL XENMATRIX GRAFT ON (B)(6) 2020, WHICH WAS USED AS AN OVERLAY AND SUTURED AT THE LEFT PUBIC BONE ALONG THE INGUINAL AND EXTERNAL OBLIQUE AND RECTUS MUSCLES. IT WAS REPORTED THAT ABOUT 4 MONTHS POST OP, THE PATIENT STARTED TO EXPERIENCE SIGNIFICANT PAIN AND TIGHTNESS, AS DESCRIBED ¿FEELS LIKE A SQUEEZING OF HIS BOWELS, SIGNIFICANT STRETCHING FROM HIS RIB CAGE TO HIS PUBIC BONE.¿ AS REPORTED, THE PATIENT HAD DIFFICULTY WITH BOWELS AND TOOK MULTIPLE LAXATIVES; THE PATIENT REACHED OUT TO THE SURGEON WHO PERFORMED THE SURGERY WHO ORDERED AN MRI ON TWO SEPARATE OCCASIONS WITH NO FINDINGS. AS REPORTED, THE PATIENT HAD A PRESCRIPTION FOR NARCOTICS BUT CHOSE TO TAKE OTC PAIN MEDICATION AS THE NARCOTIC PAIN MEDICATION CAUSES CONSTIPATION AND DID NOT WANT TO CAUSE ANY MORE ISSUES WITH HIS BOWELS. IT WAS ALSO REPORTED THAT THE PATIENT CONTINUES TO FEEL A SIGNIFICANT STRETCHING IN ABDOMEN WITH ASSOCIATED PAIN.

  Patient problems: Constipation; Pain

  MAUDE report 11607331 ↗
• InjuryNov 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT WAS IMPLANTED WITH A BARD XENMATRIX GRAFT. THE GRAFT WAS PLACE IN A CLEAN PROCEDURE. AS REPORTED APPROXIMATELY SIX YEARS LATER THE PATIENT DEVELOPED A (B)(6) INFECTION, WHICH HAS RECURRED THREE TIMES. ON (B)(6) 2018 A REVISION PROCEDURE WAS PERFORMED WITH EXCISION OF THE FASCIA, SCAR TISSUE AND EXPLANT OF POTENTIAL BIO MESH REMNANT (XENMATRIX GRAFT). THE CONTACT REPORTS THE CULTURE CAME BACK POSITIVE FOR STAFF INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 8041118 ↗
• MalfunctionMay 10, 2018Shelf Life Exceeded; Shelf Life Exceeded

  IT WAS REPORTED THAT AN EMERGENCY CASE WAS PERFORMED ON (B)(6) 2018. DURING THIS PROCEDURE A DAVOL XENMATRIX GRAFT WAS PLACED. AS REPORTED FOLLOWING THE PROCEDURE WHILE PROCESSING THE RECORDS IT WAS IDENTIFIED THAT THE LABELED EXPIRATION DATE OF THE IMPLANTED DEVICE WAS 02/28/2018. PER MATERIALS MANAGER, THE UNIT WAS FROM THE HOSPITAL INVENTORY. THE RISK MANAGER CONFIRMED THE USE ERROR ON THE PART OF THE FACILITY. THE RISK MANAGER WAS INFORMED THAT THERE WAS NO TEST DATA TO SUPPORT A LONGER SHELF LIFE FOR THE PRODUCT. HOSPITAL PLANNED TO INFORM THE PATIENT OF THE ERROR THAT OCCURRED. AT THIS TIME THERE HAS BEEN NO PATIENT COMPLICATIONS OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504361 ↗