XENMATRIX 1151520Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741074240), received between Oct 17, 2017 and Sep 3, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Material Deformation

  Per information provided:On (b)(6) 2014 - Patient was diagnosed with ventral hernia thereby underwent open repair with the implant of Ventralex ST Mesh (Device 1). Per op notes, "A supraumbilical incision was made, a Ventralex ST Mesh (Device 1) was placed into the hernia defect using prolene sutures."On (b)(6) 2015 - Patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of synthetic mesh. Per op notes, "There was noted to be the old mesh at the level of the umbilicus and on the scar tissue, the scar was excised. Then a synthetic mesh was placed."On (b)(6) 2017 - Patient underwent excision of the abdominal wall scar.On (b)(6) 2017 - Patient was diagnosed with chronic abdominal wall infection and adhesions thereby underwent repair with removal of Ventralex ST mesh (Device 1) and synthetic mesh and implant of XenMatrix AB (Device 2). (Notes: No op notes were provided).On (b)(6) 2019 - Patient was diagnosed with recurrent incisional hernia thereby underwent repair removal of mesh (Device 2). Per op notes, "Included with hernia sac the old XenMatrix AB (Device 2) which had ballooned into the defect and was adherent to the hernia s

  Patient problems: Adhesion(s); Bacterial Infection; Hernia; Obstruction/Occlusion; Pain

  MAUDE report 50588119 ↗
• InjuryMay 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿THE OLD MESH WAS NOTED RETRACTED AND CURLED OVER WAS EXCISED. THE HERNIA SAC WAS NOTED AND EXCISED. A VENTRALEX MESH (DEVICE 1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA AND OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE DEFECT FROM THE PREVIOUS MESH WAS NOTED AND THE CONTENTS OF HERNIA DEFECT WAS REDUCED AND EXCISED. THE OLD MESH (DEVICE 1) WAS WELL INCORPORATED AND DIFFICULT TO EXPLANT. THE HERNIA DEFECT WAS REPAIRED PRIMARILY WITH SUTURES.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN AND INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿MIDLINE INCISION WAS MADE. SIGNIFICANT ADHESIONS BETWEEN SMALL BOWEL AND THE OLD MESH WERE LYSED. THE RECURRENT HERNIA DEFECT WAS NOTED JUST LATERAL TO THE OLD MESH. SOME SEROUS FLUID COLLECTION ABOVE THE MESH WERE DRAINED. THE MESH (DEVICE 1) WAS EXCISED ENTIRELY. COMPONENT SEPARATION WAS PERFOR

  Patient problems: Hernia; Scar Tissue

  MAUDE report 25299807 ↗
• InjuryJun 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH REDUCIBLE LEFT INGUINAL HERNIA AND INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1) FOR LEFT INGUINAL HERNIA. PER OP NOTES, ¿A SMALL PERFIX PLUG (DEVICE #1)PLACED INTO THE PROPERITONEAL SPACE THROUGH THE INTERNAL RING AND ONLAY PATCH WAS PLACED OVER THE INTERNAL RING SECURED USING SUTURES. AN UMBILICAL HERNIA WAS REPAIRED USING SUTURES.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #2). PER OP NOTES, ¿DENSE ADHESIONS TO THE PREVIOUS HERNIA MESH WERE TAKEN DOWN COMPLETELY. THE PREVIOUSLY PLACED MESH WAS WELL INTACT. A COMPOSIX L/P MESH (DEVICE #2) WAS PLACED OVER THE DEFECT AND TACKED.¿ (B)(6) 2015 ¿ PATIENT HAD ABDOMINAL PAIN AND WAS DIAGNOSED WITH RECURRENT INCARCERATED ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2) AND IMPLANT OF XENMATRIX AB (DEVICE #3). PER OP NOTES, ¿PREVIOUSLY PLACED MESHES (DEVICE #1, #2) WERE DISSECTED FREE FROM THE SURROUNDING FASCIA WERE EXCISED. ADHESIONS WERE LYSED. A XENMATRIX AB BIOLOGICAL MESH (DEVIC

  Patient problems: Bacterial Infection; Hematoma; Seroma

  MAUDE report 22133475 ↗
• InjuryFeb 12, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH THREE INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, "THE SCARRED SUBCUTANEOUS ADIPOSE TISSUE TO A LARGE HERNIA SAC WITH TWO HERNIAS WERE NOTED. THE FASCIAL BRIDGE CONNECTING THE HERNIAS WAS OPENED CONVERTING INTO A SINGLE HERNIA. THE FASCIAL EDGES WERE FREED AND ADHERENT OMENTUM WAS TAKEN DOWN. A VENTRALEX PATCH (DEVICE #1) WAS PLACED IN FASCIAL TISSUE PLANE AND SUTURED. ANOTHER FASCIAL DEFECT WAS CLOSED PRIMARILY. THE DEFECT WAS CLOSED ON TOP OF THE PATCH." (B)(6) 2012 - PATIENT HAD SYMPTOMATIC GALL STONES THEREBY UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT MIDLINE INCISIONAL HERNIA WITH INTRABDOMINAL ADHESIONS AND PARTIAL SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF VENTRALEX (DEVICE #1) AND IMPLANT OF BARD SOFT MESH (DEVICE #2) AND XENMATRIX AB (DEVICE #3). PER OPERATIVE NOTES, "THE PRIOR MESH (DEVICE #1) HAD PULLED LOOSE FROM SURROUNDING FASCIA AND WAS EXCISED. ADHESIONS WERE NOTED TO THE SMALL BOWEL BOTH PROXIMALLY AND DISTALLY, FAIRLY AD

  Patient problems: Seroma

  MAUDE report 21362081 ↗
• MalfunctionDec 15, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  PER MW5103490, ALLEGE FAILURE OF BARD/DAVOL XENMATRIX AB GRAFT USED IN ABDOMINAL REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 15986736 ↗
• MalfunctionMay 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2020, A SURGEON HAD OPENED A PIECE OF XENMATRIX AB AND SOAKED IN NSS (NORMAL STERILE SALINE) FOR FIVE (5) MINUTES. AFTER IT WAS REMOVED, IT WAS NOTED THAT THE ORANGE COATING WAS PEELING OFF IN LARGE QUANTITIES, ONTO THE SURGEON¿S GLOVES, ETC. THE SURGEON DID NOT WANT THE LARGE SLOUGHING OF COATING TO CAUSE DAMAGE TO THE PATIENT AND DECIDED TO NOT IMPLANT THE PIECE IN QUESTION. AS REPORTED, THERE WAS NO INJURY OR IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10049301 ↗
• InjuryMar 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 INFECTION. ON (B)(6) 2018 - THE PATIENT UNDERWENT IMPLANT OF THE XENMATRIX AB GRAFT TO REPAIR A PRIMARY INCISIONAL HERNIA.THE WOUND SITE WAS CLASSIFIED AS CLEAN WITH NO EXISTING INFECTION. A RETRO-RECTUS WITHOUT COMPONENT SEPARATION TECHNIQUE WAS PERFORMED. THERE WAS A SWISS CHEESE CONFIGURATION (MULTIPLE DISCREET HERNIAS) PRESENT. THE TOTAL HERNIA DEFECT WAS MEASURED TO BE 15CM IN LENGTH AND 10CM IN WIDTH. IT WAS NECESSARY TO TRIM THE GRAFT AND AN OVERLAP OF 5CM WAS MAINTAINED AROUND THE HERNIA DEFECT. THE HERNIA WAS LOCATED IN THE SUBXIPHOID, EPIGASTRIC AND UMBILICAL AREA OF THE ABDOMEN. LONG-TERM ABSORBABLE MONOFILAMENT SUTURE WAS USED WITH 12 FIXATION POINTS. THE MIDLINE FASCIA WAS COMPLETELY CLOSED AND THE SKIN WAS FULLY CLOSED WITH STAPLES. A DRAIN WAS INSERTED IN THE LEFT LOWER QUADRANT. ON (B)(6) 2018 - REMOVAL OF DRAIN FROM THE LEFT LOWER QUADRANT. ON (B)(6) 2018 - DURING A POST OPERATIVE VISIT THE PATIENT WAS DIAGNOSED WITH AN INCISION SITE INFECTION. ALSO NOTED WAS A SMALL AREA OF ERYTHEMA OVER THE INFRAUMBILICAL PORTION OF THE INCISION. NO CULTURES WERE OBTAINED. THE PAT

  Patient problems: Erythema; Seroma; Unspecified Infection

  MAUDE report 7319822 ↗
• MalfunctionOct 17, 2017Shelf Life Exceeded; Shelf Life Exceeded

  IT WAS REPORTED THAT AN EXPIRED XENMATRIX AB GRAFT WAS PLACED IN A PATIENT IN ERROR. AS REPORTED THE SURGEON ELECTED TO LEAVE THE DEVICE IN PLACE. THE CONTACT STATES THE SURGEON PERFORMED A VISUAL ASSESSMENT OF THE GRAFT PRIOR TO IMPLANTING. TO DATE THERE HAS BEEN NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6956382 ↗