XENMATRIX 1151015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741074226), received between Aug 17, 2018 and Feb 12, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿THE LARGE CHRONIC HERNIA SAC WAS EXCISED. THERE WAS A SEPARATE HERNIA NEAR THE UMBILICUS FROM CHRONIC INCISION. THE SEPRAMESH IP (DEVICE 1) WAS PLACED TO COVER ALL THE DEFECTS AND FASCIA WAS CLOSED PRIMARILY USING SUTURES. THEN THE MESH WAS TACKED ALL AROUND THE EDGE AND HERNIA ITSELF USING PROTACKS.¿ (B)(6) 2017 ¿ PATIENT HAD PAIN AND WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, ABSCESS, INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF XENMATRIX AB (DEVICE 2). PER OP NOTES, ¿THE ABSCESS CAVITY FULL OF GROSS PUS WAS SUCTIONED OUT. IN CAVITY, SUTURES AND MESH WAS NOTED. ADHESION WAS TAKEN DOWN. THE MESH (DEVICE 1) WAS REMOVED AND FASCIAL DEFECT WAS ENCOUNTERED. A PIECE OF XENMATRIX AB (DEVICE 2) WAS PLACED AS UNDERLAY TO REPAIR THE DEFECT AND ANCHORED TO FASCIA WITH SUTURE. THE MESH WAS TACKED CIRCUMFERENTIALLY TO ANTERIOR ABDOMINAL WALL.¿ 07-NOV-2017 ¿ PATIENT HAD ABDOMINAL PAIN AND WAS DIAGNOSED WITH NECROTIC OPEN ABDOMINAL WOUND THEREBY UN

  Patient problems: Abdominal Pain; Necrosis; Wound Dehiscence

  MAUDE report 24321655 ↗
• InjuryJan 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA X 2 THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OP NOTES, ¿TWO SEPARATE HERNIAL DEFECTS BOTH WITH INCARCERATED OMENTUM AND ONE WITH SOME SMALL BOWEL LOOPS WERE IDENTIFIED. THE CONTENTS OF THE HERNIA WAS TAKEN DOWN. A PIECE OF COMPOSIX E/X MESH (DEVICE 1) WAS PLACED AND FIXED WITH THE ABSORBATACK.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA X 2 THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX AB MESH (DEVICE 2). PER OP NOTES, ¿HERNIA DEFECT WAS IDENTIFIED AND THE SAC WAS FORMED AT THE EDGE OF PREVIOUS MESH (DEVICE 1) REPAIR. REMOVED 2 STAPLES FROM PREVIOUS REPAIR. COMPLEX ABDOMINAL WALL AND THICK PREPERITONEAL FAT LAYER WAS NOTED AND BOTH DEFECTS WERE SUTURED. A PIECE OF XENMATRIX AB MESH (DEVICE 2) WAS PLACED OVERLYING BOTH DEFECTS AND SECURED WITH SUTURES.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH SEROMA OF ABDOMINAL WALL THEREBY UNDERWENT DRAINAGE. PER OP NOTES ¿UPPER LEVEL OF SEROMA WAS IDENTIFIED AND OLD METABOLIZED HEMATOMA WAS SUCTIONED OUT. A JACKSON-PART DRAIN WAS PLACED IN THE SEROMA CAVITY AND SUT

  Patient problems: Hematoma; Seroma

  MAUDE report 23952898 ↗
• InjuryDec 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER FDA: DURING A SURGICAL PROCEDURE ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH XENMATRIX AB. AS REPORTED, THE PATIENT STARTED FEELING SYMPTOMS LIKE POOR BOWEL MOVEMENT WHICH HE ADDRESSED WITH HIS PRIMARY CARE DOCTOR ON (B)(6) 2022. THIS LED TO SURGERY AT ANOTHER HOSPITAL AS THE DOCTOR HAD FOUND 2 HERNIAS DURING AN EXAMINATION. SURGERY WAS PERFORMED, AND THE DOCTOR PLACED A MEDICAL PATCH OVER THE DEVICE.

  Patient problems: Hernia

  MAUDE report 16009867 ↗
• InjuryDec 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER MEDICAL RECORDS PROVIDED: THE PATIENT PRESENTED WITH SYMPTOMS OF A CORE MUSCLE INJURY AND PERSISTENT GROIN PAIN. PER THE OPERATIVE DETAILS, THE PREVIOUS RECTUS ABDOMINIS LEFT SIDED REPAIR WAS INTACT. "THERE WERE MULTIPLE OTHER AREAS OF SCAR TISSUE... THIS WAS MOBILIZED UP THE ENTIRE RECTUS ABDOMINIS MUSCLE ABOVE AND BELOW, CUT THROUGH MULTIPLE BUNDLES OF SCAR TISSUE, AND MANEUVERED THE MUSCLE TO FILL IN THE GAP BY DOING SO. MULTIPLE 2-CHROMIC SUTURES WERE USED TO APPROXIMATE THE MUSCLE. THUS, THE GAP WAS REPLACED WITH INTACT MUSCLE. A W-PLASTY WAS PERFORMED USING A COMBINATION OF SUTURES TO DECOMPRESS THE COMPARTMENT. A 10 X 15 CM PIECE OF XENMATRIX AB MESH WAS FITTED AND PLACED IN AN OVERLYING FASHION. THIS WAS ALSO ATTACHED WITH ETHIBOND AT THE PUBIC BONE AND ALONG INGUINAL LIGAMENT. THIS WAS ALSO SECURED AT THE EXTERNAL OBLIQUE AND RECTUS ABDOMINIS MUSCLES BILATERALLY." PER CONTACT SINCE IMPLANT THE GRAFT HAD BECOME "TIGHTER AND TIGHTER IN THE ABDOMEN AND THE PATIENT IS IN SIGNIFICANT PAIN.¿ CONTACT REPORTS THAT THE PATIENT HAD UNDERGONE THREE PRIOR SURGERIES FOR ¿BASICALLY THE SAME PROBLEM" AND DOCTORS NOW RECOMMEND AGGRESSIVE DRY NEEDLING OF THE RECTUS ABDOMINIS.

  Patient problems: Pain

  MAUDE report 15991986 ↗
• InjuryMay 28, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2004 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD COMPOSIX WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2004 THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR REPAIR OF A RECURRENT INCISIONAL HERNIA. THE SURGEON TOOK DOWN THE ADHESIONS THAT WERE ENCOUNTERED. A BARD COMPOSIX WAS IMPLANTED TO REPAIR THE RECURRENT HERNIA DEFECT. ON OR ABOUT (B)(6) 2008, PATIENT UNDERWENT SURGERY TO REMOVE THE COMPOSIX AND REPAIR THE RECURRENT INCISIONAL HERNIA. ADDITIONALLY, DURING THIS SURGERY, THE SURGEON TOOK DOWN THE ADHESIONS AND EXCISED THE MESH. THEN, A NON-BARD/DAVOL MESH WAS IMPLANTED TO ATTEMPT TO REPAIR THE RECURRENT HERNIA DEFECT. ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT ADDITIONAL SURGERY TO REMOVE THE PREVIOUSLY PLACED MESH AND REPAIR RECURRENT HERNIAS. AFTER ENTERING THE ABDOMEN, THE SURGEON FOUND EXTENSIVE BOWEL ADHESIONS TO THE MESH, WHICH CAUSED A PARTIAL BOWEL OBSTRUCTION. AFTER EXTENSIVELY LYSING THE BOWEL ADHESIONS, THE SURGEON HAD TO PERFORM TWO BOWEL RESECTIONS AND ANASTOMOSES. THE MESH WAS THEN EXPLANTED WITH DENSE SCAR TISSUE AND ADHESIONS. THE SURGEON PLACED A BARD XENMATRIX AB IN AN ATTEMPT

  Patient problems: Disability; Injury; Pain

  MAUDE report 10098474 ↗
• InjuryAug 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY HAD EXPERIENCED PAIN AND DIARRHEA. ON (B)(6) 2017 - THE PATIENT UNDERWENT A PRIMARY INCISIONAL INFRAUMBILICAL HERNIA REPAIR WITH IMPLANT OF THE XENMATRIX AB GRAFT. INTRAPERITONEAL WITHOUT COMPONENT SEPARATION TECHNIQUE WAS USED. THE XENMATRIX AB GRAFT WAS NOT TRIMMED AND A 5MM GRAFT OVERLAP WAS MAINTAINED AROUND THE HERNIA DEFECT. ON (B)(6) 2018 - THE PATIENT WAS ASSESSED TO HAVE A CLEAR AND CLEAN INCISION, NO ERYTHEMA AND NO RECURRENT HERNIA. ON (B)(6) 2018 - THE PATIENT WAS ASSESSED TO HAVE A WELL HEALED INCISION AND NO EVIDENCE OF A HERNIA. ON (B)(6) 2018 - THE PATIENT WAS HOSPITALIZED FOR ABDOMINAL PAIN AND DIARRHEA. SHE WAS GIVEN IV FLUIDS AND PAIN MEDICATION. ON (B)(6) 2018 - THE PATIENT WAS DISCHARGED WITH A STATUS OF RECOVERED / RESOLVED. THIS EVENT HAS BEEN ASSESSED BY THE CLINICIAN AS SEVERE, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO BE IMPLANT PROCEDURE.

  Patient problems: Abdominal Pain; Diarrhea

  MAUDE report 7793820 ↗