XENMATRIX 1161928Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741031434), received between Nov 21, 2017 and Oct 31, 2025 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A VENTRIO MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SUTURED.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRIO MESH (DEVICE 1) AND AN IMPLANT OF XENMATRIX SURGICAL GRAFT (DEVICE 2). PER OPERATIVE NOTES, ¿THE VENTRIO MESH (DEVICE 1) WAS SOMEWHAT BALLED UP AND WAS COMPLETELY REMOVED. A XENMATRIX SURGICAL GRAFT (DEVICE 2) WAS PLACED INTO THE ABDOMEN AND SUTURED.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT HERNIA WITH MULTIPLE MESHES THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF XENMATRIX SURGICAL GRAFT (DEVICE 2) AND AN IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3) AND PHASIX MESH (DEVICE 4) AND LYSIS OF ADHESIONS. (NOTE: THE OP NOTES PROVIDED FOR THIS PROCEDURE IS INCOMPLETE)

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23438152 ↗
• InjuryAug 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC TO OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE LARGE HERNIA DEFECT WAS NOTED. A LARGE PIECE OF VENTRIO MESH (DEVICE #1) WAS PLACED AND TACKED CIRCUMFERENTIALLY USING SUTURES.¿ (B)(6) 2013 ¿ PATIENT HAD ABDOMINAL PAIN AND WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE LYSIS OF ADHESION. PER OPERATIVE NOTES, ¿A DENSE AMOUNT OF ADHESION TO ANTERIOR ABDOMINAL WALL AND MESH (DEVICE #1) WERE TAKEN DOWN. A PORTION OF THE SMALL BOWEL HAD AREA OF STRICTURED WAS RESECTED AND ANASTOMOSED SIDE TO SIDE FASHION.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH DEEP SURGICAL SITE INFECTION THEREBY UNDERWENT DEBRIDEMENT OF WOUND. PER OPERATIVE NOTES, ¿SUTURES WERE REMOVED TO REVEAL A LARGE AMOUNT OF PURULENT MATERIAL. SOME OF NECROTIC SUBCUTANEOUS TISSUE WERE DEBRIDED.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS THEREBY UNDERWENT INCISION AND DRAINAGE OF ABSCESS. PER OPERATIVE NOTES, ¿THE ABSCESS POCKET WAS IDENTIFIED, AND LARGE AMOUNT OF PURULENT DRAINAGE WAS EXPRESSED

  Patient problems: Seroma

  MAUDE report 22748983 ↗
• InjuryJun 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE # 1). PER OP NOTES, ¿THERE WAS A BRIDGE OF MESH PREVIOUSLY PLACED BETWEEN THE TWO FASCIAL DEFECTS. THE INCARCERATED OMENTUM WHICH WAS ADHERENT TO THE HERNIA SAC WAS EXCISED. A BARD COMPOSIX E/X MESH (DEVICE # 1) WAS PLACED IN THE PERITONEUM AND SECURED SUBLAY USING SUTURES.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION SECONDARY TO ADHESIONS THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE ENTIRE MESH WAS COVERED WITH ADHESIONS TO THE BOWEL. THERE WAS ONE LOOP ON THE LEFT SIDE OF THE MESH WAS DENSELY ADHERENT WAS SCRAPPED OFF.¿ ON (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION SECONDARY TO INCARCERATED RECURRENT INCISIONAL VENTRAL HERNIA AND ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE # 1) AND IMPLANT OF XENMATRIX MESH (DEVICE 2). PER OP NOTES, ¿A VERY DILATED SMALL BOWEL WAS FOUND. PATIENT HAD A BRIDGE OF OLD MESH (DEVICE #1) BETWEEN THE UPPER DEFECT AND THE LOWER DEFECT WERE REMOVED AND THE MESH WAS DIVIDED. THERE WERE EXTENSIVE ADHESIONS

  Patient problems: Adhesion(s); Seroma; Unspecified Infection

  MAUDE report 22305671 ↗
• InjuryJun 18, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  PER INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL DEFECT HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, "A BARD FLAT MESH (DEVICE #1) WAS PLACED AND TACKED." ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH VULVAR ABSCESS THEREBY UNDERWENT DRAINAGE OF ABSCESS ON LEFT. ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH POST NEOVAGINA CREATION AND STRESS URINARY INCONTINENCE THEREBY UNDERWENT BURCH URETHROPEXY. ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH FISTULA AND VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF XENMATRIX MESH (DEVICE #2) AND RESECTION OF FISTULA AND COLON WITH LONG HARTMANN. PER OPERATIVE NOTES, "LYSIS OF ADHESIONS PERFORMED. THE XENMATRIX MESH (DEVICE #2) WAS PLACED IN AN INTERPOSITION FASHION AND SUTURED." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH OPEN WOUND THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE #2) AND IMPLANT OF VENTRALIGHT ST (DEVICE #3). PER OPERATIVE NOTES, "THE MESH (DEVICE #2) HAD SEPARATED AND FAILED. THE MESH WAS REMOVED. SUTURE ABSCESS WAS FOUND ON LEFT UPPER QUADRANT. ADHESIONS BETWEEN FASCIA AND BOWEL WAS REMOVED. A

  Patient problems: Abscess; Adhesion(s)

  MAUDE report 22268467 ↗
• InjuryAug 16, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2014, THE PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL MIDLINE OPEN HERNIA REPAIR PROCEDURE DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION, FIXATED USING MAXON SUTURES. FASCIA WAS COMPLETELY CLOSED USING MAXON SUTURE THROUGH INTERRUPTED STITCH AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. CONCOMITANT PROCEDURE INCLUDED PANNICULECTOMY AND LYSIS OF ADHESION(S). THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH SUPERFICIAL WOUND DEHISCENCE WHICH RESOLVED ON (B)(6) 2015. THE AE (WOUND DEHISCENCE) IS CLINICALLY ASSESSED TO BE OF MILD SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE, POSSIBLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT). ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH SEROMA AND HOSPITALIZED ON (B)(6) 2015. ON (B)(6)2015 PATIENT UNDERWENT A SURGERY FOR THE SEROMA. FASCIA WAS COMPLETELY CLOSED USING VICRYL SUTURE THROUGH INTERRUPTED STITCH AND FULL SKIN CLOSURE WAS ACHIEVED. THE PATIENT WAS DISCHARGED HOME THE SAME DAY. THE AE (SEROMA) IS CLINICALLY ASS

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 15234615 ↗
• InjuryNov 23, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH AND XENMATRIX ON (B)(6) 2010 AND/OR (B)(6) 2012 AND/OR (B)(6) 20XX (INCOMPLETE DATE VISIBLE ON LEGAL CLAIM). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Impaired Healing; Insufficient Information; Unspecified Infection

  MAUDE report 12860115 ↗
• InjuryOct 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT REPAIR OF AN ABDOMINAL HERNIA AND WAS IMPLANTED WITH TWO XENMATRIX GRAFTS (DEVICES #1 AND #2), AND A NON BARD/DAVOL BIOLOGIC GRAFT (DEVICE #3). THE CONTACT REPORTS THE HERNIA REPAIR WOUND NEVER FULLY HEALED, AND IN 2014 THE PATIENT DEVELOPED AN INFECTION IN THE AREA OF THE HERNIA REPAIR. AS REPORTED THE PATIENT'S DOCTOR HAS ADVISED HIM THE MESH WILL NEED TO BE REMOVED.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 7980491 ↗
• InjuryMar 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT IS REPORTED THAT THE PATIENT DEVELOPED A RECURRENCE INCISIONAL HERNIA AND UNDERWENT AN EXTENSIVE LAPAROTOMY DURING WHICH ADHESIOLYSIS HAD TO BE PERFORMED. THE PATIENT WAS TAKEN BACK INTO THEATRE TWO DAYS FOLLOWING THIS PROCEDURE TO HAVE A DAVOL XENMATRIX GRAFT PLACED. IT IS REPORTED THAT TWO DAYS POST IMPLANT OF THE GRAFT THE PATIENT STARTED EXPERIENCING TACHYCARDIA (A RAPID RESTING HEARTBEAT). AS REPORTED THE ANESTHETIST HAS RULED OUT OTHER POSSIBLE EVENTS THAT MAY CAUSE TACHYCARDIA AND IS NOW INQUIRING ABOUT THE MESH AS THIS IS THE ONLY OTHER VARIABLE. IT IS REPORTED THAT WHEN THE PRODUCT WAS PLACED, THERE WERE NO PHYSICAL DEFECTS. IT WAS WELL WITHIN EXPIRY DATE AND HAD BEEN STORED IN A COOLING FRIDGE. AS REPORTED THE PATIENT HAS A MEDICAL / SURGICAL HISTORY SIGNIFICANT FOR MULTIPLE RECURRENT HERNIAS AND REPAIR. AS REPORTED OVER THE LAST 10 YEARS THE PATIENT HAS HAD 4 X SYNTHETIC MESHES PLACED, AND JUST OVER A YEAR AGO HAD 1 X BIOLOGIC MESH PLACED (NON-DAVOL PRODUCT).

  Patient problems: Tachycardia

  MAUDE report 7310321 ↗
• InjuryNov 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO DAVOL VIA MEDWATCH 3500A / (B)(4). MULTIPLE RECURRENCE INCISION HERNIAS. WILL GET A PRE OPERATIVE CT. IT IS HARD TO GET A SIZE OF THE HERNIAS DUE TO HIS OBESITY. WILL TRY A LAP HERNIA REPAIR BUT I THINK THERE IS A HIGH CHANCE OF CONVERSION DUE TO THE EXTENT OF HIS PREVIOUS REPAIRS. HE FIRST NOTICED IT 1 YEAR AGO. IT IS LOCATED IN THE UPPER VENTRAL AREA. HE HAS NOTICED IT GETTING BIGGER IN SIZE. PRIOR HERNIAS; YES. PAIN SEVERITY MODERATE. PAIN QUALITY-STABBING AND SHARP. PAIN RADIATES-NO. ALLEVIATING FACTORS-RELAXATION. AGGRAVATING FACTORS-BENDING OVER AND LIFTING. ATTEMPTED LAPAROSCOPIC INCISIONAL HERNIA REPAIR, CONVERTED TO OPEN DUE TO DENSE ABDOMINAL ADHESIONS, EXPLANTATION OF SYNTHETIC AND ENDS SYMPATHETIC AND PORCINE MESH IMPLANTS AND REIMPLANTATION OF A 20 X 30 CM MESH. I FIRST DID A CUT DOWN IN THE LEFT UPPER QUADRANT, AS PATIENT HAD PREVIOUS MULTIPLE MIDLINE INCISIONS AND A KOCHER INCISION AS WELL. I GOT DOWN TO FASCIA AND HE WAS SO DEEP THAT WHEN I ENTERED THE ABDOMEN, THERE WERE EXTENSIVE ADHESIONS AND I COULD NOT TELL WHAT WAS BOWEL. ALSO, I COULD FEEL WHAT APPEARED TO BE EDGE OF MESH RIGHT IN THIS AREA, EVEN THOUGH I WAS VERY LATERAL. I DECI

  Patient problems: Adhesion(s); Hernia

  MAUDE report 7049826 ↗