XENMATRIX 1152025Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741074288), received between Apr 11, 2017 and Feb 26, 2026 — classified as 1 death, 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THREE DISCRETE DEFECTS IN A ROW WERE NOTED AND CONNECTED. THE FASCIA WAS CLOSED WITH SUTURES AND BARD FLAT MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED WITH SUTURES.¿ (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF PRIOR MESH (DEVICE 1) AND IMPLANT OF XENMATRIX AB MESH (DEVICE 2) AND PHASIX MESH (DEVICE 3). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THE PRIOR MESH (DEVICE 1) WAS HARDENED AND FILL THE VENTRAL HERNIA. ADHESIONS WERE LYSED AND HERNIA ONE ABOVE AND BELOW THE BELLYBUTTON WERE REDUCED. THE PRIOR MESH (DEVICE 1) WAS PARTIALLY REMOVED AND ABSCESS WAS DRAINED. THE XENMATRIX AB MESH (DEVICE 2) WAS PLACED OVER THE FASCIA AND REAPPROXIMATED WITH SUTURES. THE FASCIA WAS REINFORCED AND PHASIX MESH (DEVICE 3) WAS PLACED AND SECURED WITH SUTURES AND OPTIFIX TACKERS.¿ (B)(6) 2016: PATIENT WAS DIAGNOSED WITH INFECTED WOUND THEREBY UNDERWENT INCISION AND DRAINAGE OF INFECTED WOUND AND SEROMA. PE

  Patient problems: Necrosis; Post Operative Wound Infection; Seroma

  MAUDE report 24454606 ↗
• DeathApr 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER MEDWATCH REPORT (MW5167617), "ALLEGED EVENT: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH 1ST STRATTICE ON (B)(6) 2016 AND 2ND STRATTICE ON (B)(6) 2017. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN REMOVED OR REVISED. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION. PATIENT HAS DIED ON (B)(6) 2022 AND THERE IS NO FURTHER DETAILS ON DEATH CAUSALITY. THIS RECORD CAPTURED 1ST STRATTICE. ON (B)(6) 2025, (B)(6) RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT WAS BORN WITH AN ABDOMINAL WALL DEFECT (GASTROSCHISIS), WHO UNDERWENT A VENTRAL HERNIA SURGERY AND WAS IMPLANTED WITH A STRATTICE DEVICE LOT SP100381-101 ON (B)(6) 2016. THE PATIENT UNDERWENT AN OPEN VENTRAL INCISIONAL HERNIA REPAIR WITH BIOLOGICAL MESH ON (B)(6) 2017. THE PATIENT WAS IMPLANTED WITH A SECOND STRATTICE DEVICE LOT SP100537-078 ON THE SAME DATE. THE PATIENT THEN UNDERWENT AN INCISIONAL/VENTRAL HERNIA REPAIR WITH BIOLOGIC MESH ON (B)(6) 2018 AND IMPLANTED WITH A THIRD STRATTICE DEVI

  Patient problems: Abdominal Pain; Adhesion(s); Fluid Discharge; Hernia; Obstruction/Occlusion

  MAUDE report 21761312 ↗
• InjuryMar 19, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND LARGE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, "AT MIDLINE INSERTION, THE HERNIA EXTENDS ALL WAY FROM XIPHISTERNUM TO THE PUBIC TUBERCLE. THERE WERE ALSO SEPARATED HERNIAS IN UMBILICAL AREA AND SMALL BOWEL PARTIAL OBSTRUCTION. A SEPRAFILM WAS PLACED IN THE PELVIC AREA OVER THE SMALL BOWEL, EXCESS PORTION OF THE HERNIAL SAC WAS EXCISED AND REMAINING PART OF THE SAC WAS SUTURED TO COVER THE PERITONEUM. THEN A PIECE OF SEPRAMESH IP (DEVICE #1) WAS CUT INTO THE SHAPE OF THE DEFECT AND SUTURED IN PLACE. EXCESS PORTION OF MESH WAS EXCISED. A JP DRAIN WAS INSERTED." ON (B)(6) 2013 TO ON (B)(6) 2014: PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN, ABDOMINAL CELLULITIS, ABSCESS AND LOCALIZED WOUND INFECTION WITH SOME DRAINAGE THEREBY REMOVED THE DRAIN AND TREATED WITH MEDICATIONS DURING OPEN WOUND MANAGEMENT. ON (B)(6) 2014: PATIENT WAS DIAGNOSED WITH DRAINING MIDLINE WOUND AND MESH INFECTION THEREBY UNDERWENT REPAIR. PER OPERATIVE NOTES, "SCAR AND SINUS TRACTS WERE REMOVED WITH AN OLD PIECE OF SUTURE MATE

  Patient problems: Purulent Discharge

  MAUDE report 18927917 ↗
• InjuryFeb 18, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WAS IMPLANTED WITH A BARD/DAVOL XENMATRIX AB GRAFT ON (B)(6) 2020 AFTER WHICH THE PATIENT EXPERIENCED POST-OP FLUID DEVELOPMENT AND UNDERWENT A PARTIAL EXPLANT, ABOUT 6 MONTHS AGO. AS REPORTED, THOUGH THE SURGEON HAD RE-OPERATED (DATE UNKNOWN) AND PLACED ANOTHER BARD/DAVOL XENMATRIX AB GRAFT, THE PATIENT EXPERIENCED THE SAME POSTOPERATIVE SYMPTOMS OF FLUID DEVELOPMENT AND DRAINAGE. THE SURGEON SUSPECTS THE PATIENT TO HAVE AN ALLERGIC REACTION AGAINST A COMPONENT OF THE GRAFT. THE PATIENT WAS DOING WELL WITH NO ADDITIONAL SURGICAL TREATMENT PLANNED AND WILL BE MONITORED BY THE SURGEON AT THIS TIME.

  Patient problems: Local Reaction; Reaction; Seroma

  MAUDE report 11342882 ↗
• InjuryFeb 11, 2021Material Separation; Patient Device Interaction Problem; Material Separation; Patient Device Interaction Problem

  AS REPORTED PER MEDWATCH REPORT (B)(4) ALLEGING ADVERSE OUTCOMES AGAINST BARD/DAVOL XENMATRIX AB GRAFT: "PATIENT WENT TO THE OR FOR EXPLORATORY ABDOMINAL LAPAROTOMY, ILEOSTOMY TAKEDOWN, VENTRAL HERNIA REPAIR WITH WITHOUT AND BILATERAL URETERAL STENT PLACEMENT. THE NEXT DAY, PATIENT WAS BROUGHT BACK TO THE OR FOR BILIOUS LEAKAGE AT THE SURGICAL SITE. WE BEGAN BY EXAMINING THE ILEOSTOMY SITE WOUND AND NOTED A LIKELY DEFECT IN THE MESH (XENMATRIX AB GRAFT). WE REMOVED ALL OF THE PREVIOUSLY PLACED STAPLES FROM THE MIDLINE TO BETTER VISUALIZE THE MESH. WE IDENTIFIED A 5CM LINEAR DEFECT IN THE RIGHT LOWER QUADRANT MESH THAT WAS COMPLETELY SEPARATE FROM THE EDGE OF THE MESH AND NOT RELATED TO ANY NEEDLE HOLE DEFECTS. WE COULD SEE BOWEL UNDERNEATH AND NOTED BILIOUS FLUID, CONCERNING FOR BOWEL INJURY. WE MADE PLANS TO REMOVE THE MESH FOR BETTER VISUALIZATION; ALL OF THE PREVIOUSLY PLACED CIRCUMFERENTIAL PROLENE SUTURES WERE REMOVED AND THE MESH WAS REMOVED FROM THE ABDOMEN. WE THEN IDENTIFIED A SEVERAL MILLIMETER WIDE FULL-THICKNESS SMALL BOWEL INJURY IN THE BOWEL THAT HAD BEEN UNDERLYING THE AREA OF COMPROMISED MESH." ADDENDUM PER ADDITIONAL INFORMATION: AS REPORTED PER CONTACT, THE PATIEN

  Patient problems: Bowel Perforation; Fluid Discharge

  MAUDE report 11313072 ↗
• InjuryJun 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED AND IS ASSOCIATED WITH A CLINICAL STUDY. ON (B)(6) 2016 AT THE TIME OF IMPLANT THE HERNIA SITE WOUND WAS CLASSIFIED AS A CLASS 1 (CLEAN) WITH NO EXISTING INFECTION. THE INDEX PROCEDURE INCLUDED A PARTIAL MESH (UNKNOWN) EXCISION AND EXTENSIVE LYSIS OF ADHESIONS. THE UNKNOWN MESH WAS REMOVED DUE TO THE EXTENT OF THE ADHESIONS. THE EXISTING HERNIA REPAIR WAS PERFORMED WITH A RETRO-RECTUS TECHNIQUE WITHOUT COMPONENT SEPARATION. THE HERNIA DEFECT WAS MEASURED WITH A LENGTH OF 25CM AND WIDTH OF 14CM. THE XENMATRIX AB GRAFT WAS TRIMMED PRIOR TO PLACEMENT. THERE WAS A GRAFT OVERLAP OF AT LEAST 5CM AROUND THE HERNIA DEFECT. THE HERNIA LOCATION IS LISTED TO HAVE ENCOMPASSED THE SUBXIPHOID, EPIGASTRIC, UMBILICAL AND INFRAUMBILICAL AREA. THE GRAFT WAS SUTURE FIXATED. A SURGICAL DRAIN WAS PLACED IN THE RIGHT LOWER QUADRANT, RECTO-RECTUS SPACE. FOLLOWING THE IMPLANT PROCEDURE DURING THE TIME PERIOD OF (B)(6) 2016 - (B)(6) 2016 THE PATIENT WAS TREATED FOR MULTIPLE ADVERSE EVENTS (DEHYDRATION, SEROMA, ABDOMINAL PAIN, DIARRHEA) THESE EVENTS HAVE RESOLVED. THE PATIENT WAS HOSPITALIZED (B)(6) 2018-(B)(6) 2018 AND DIAGNOSED WITH ILEAL DIVERTICULITIS. THIS EVENT WAS ASSESSED

  Patient problems: Obstruction/Occlusion

  MAUDE report 7626759 ↗
• InjuryApr 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY HAS BEEN DIAGNOSED WITH A SEROMA. ON (B)(6) 2017- THE PATIENT UNDERWENT THE REPAIR OF A RECURRENT HERNIA AND WAS IMPLANTED WITH A XENMATRIX AB GRAFT. DURING THIS PROCEDURE THE PATIENT ALSO UNDERWENT THE EXPLANT OF A NON DAVOL MESH DEVICE THAT WAS IMPLANTED ON (B)(6) 2014 AND A BOWEL RESECTION. DUE TO THE NATURE OF THE PROCEDURE THE WOUND CLASSIFICATION HAS BEEN CONSIDERED TO BE CLASS 3 (CONTAMINATED). AN INTRAPERITONEAL TECHNIQUE WITH COMPONENT SEPARATION TECHNIQUE WAS PERFORMED. THERE WAS A FISTULA PRESENT AT THE TIME OF SURGERY. THE XENMATRIX AB GRAFT WAS TRIMMED AND A 5CM GRAFT OVERLAP WAS MAINTAINED AROUND THE HERNIA DEFECT. LONG-TERM ABSORBABLE MONOFILAMENT SUTURE WAS USED TO FIXATE THE GRAFT. THE MIDLINE FASCIA AND SKIN WERE COMPLETELY CLOSED. AT THE CLOSE OF THE PROCEDURE, THE WOUND CLASS WAS CHANGED TO A CLASS 4 DUE TO THE EC FISTULA. DRAINS WERE PLACED IN THE SUBCUTANEOUS LEFT LOWER QUADRANT AND THE SUBCUTANEOUS RIGHT LOWER QUADRANT. ON (B)(6) 2017- THE PATIENT DIAGNOSED WITH A SEROMA. THE SEROMA HAS BEEN ASSESSED BY THE CLINICIAN AS BEING POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDU

  Patient problems: Seroma

  MAUDE report 7439400 ↗
• InjuryApr 17, 2018Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  AS INITIALLY REPORTED ON (B)(6) 2018: IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A POST OPERATIVE WOUND INFECTION. ON (B)(6) 2017 THE SUBJECT PATIENT UNDERWENT REPAIR OF LARGE VENTRAL HERNIA USING THE XENMATRIX AB GRAFT. THE HERNIA SITE WOUND HAS BEEN ASSESSED AS A CLASS 1 (CLEAN) SITE. A RETRO-RECTUS WITH COMPONENT SEPARATION TECHNIQUE WAS PERFORMED. THE GRAFT WAS NOT TRIMMED AND A 5CM GRAFT OVERLAP WAS MAINTAINED AROUND THE HERNIA DEFECT. ABSORBABLE MONOFILAMENT SUTURE WAS USED TO FIXATE THE GRAFT. THE MIDLINE FASCIA AND SKIN WERE FULLY CLOSED. FOUR DRAINS WERE INSERTED WITH TWO PLACED BETWEEN THE SUBCUTANEOUS TISSUE AND ANTERIOR FASCIA AND THE OTHER TWO WERE PLACED OVER THE MESH AND UNDERNEATH THE FASCIA CLOSURE. ON (B)(6) 2017 ALL DRAINS WERE REMOVED. ON (B)(6) 2017 UPON PHYSICAL EXAM, THE SUBJECT PATIENT WAS NOTED TO HAVE "TWO AREAS OF WOUND OPENING. ON (B)(6) 2017 THE SUBJECT PATIENT WAS ADMINISTERED ANTIBIOTICS FOR SKIN LESION AND DEEP INCISIONAL WOUND INFECTION/ABSCESS. THE PATIENT UNDERWENT REOPERATION FOR ASPIRATION AND DEEP TISSUE CULTURES. CULTURES REVEALED A BACTERIAL INFECTION OF STREPTOCOCCUS PYGENES. ON (B)(6) 2017 THE SUBJEC

  Patient problems: Abscess; Bacterial Infection; Hernia

  MAUDE report 7438103 ↗
• InjuryApr 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED AND IS ASSOCIATED WITH THE (B)(4). ON (B)(6) 2016 - THE PATIENT WAS IMPLANTED WITH A BARD XENMATRIX AB GRAFT FOR THE TREATMENT OF A RECURRENT VENTRAL INCISIONAL HERNIA. THE PROCEDURE INCLUDED A PARTIAL MESH (UNKNOWN) EXCISION AND EXTENSIVE LYSIS OF ADHESIONS. THE UNKNOWN MESH WAS REMOVED DUE TO THE EXTENT OF THE ADHESIONS. THE EXISTING HERNIA REPAIR WAS PERFORMED WITH A RETRO-RECTUS TECHNIQUE WITHOUT COMPONENT SEPARATION. THE HERNIA DEFECT WAS MEASURED WITH A LENGTH OF 25CM AND WIDTH OF 14CM. THE XENMATRIX AB GRAFT WAS TRIMMED PRIOR TO PLACEMENT. THERE WAS A GRAFT OVERLAP OF AT LEAST 5CM AROUND THE HERNIA DEFECT. THE HERNIA LOCATION IS LISTED TO HAVE ENCOMPASSED THE SUBXIPHOID, EPIGASTRIC, UMBILICAL AND INFRAUMBILICAL AREA. THE GRAFT WAS SUTURE FIXATED. A SURGICAL DRAIN WAS PLACED IN THE RIGHT LOWER QUADRANT, RECTO-RECTUS SPACE. ON (B)(6) 2016- THE PATIENT PRESENTED FOR HER THREE MONTH POSTOP VISIT. A 3CM X 3CM, SOFT NON TENDER SEROMA BELOW THE UMBILICUS WAS REVEALED. THERE WAS NO MEDICAL / SURGICAL INTERVENTION. THE SEROMA WAS ASSESSED AS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. ON (B)(6) 2016 - THE PATIENT WAS DIAGNOSED WI

  Patient problems: Pain; Seroma

  MAUDE report 6479687 ↗