Xenform™ M0068302430Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729774464), received between Mar 16, 2020 and May 28, 2025 — classified as 8 injuries.

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.

• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, SOMETIME AFTER A HYSTERECTOMY, THE PATIENT DEVELOPED BLADDER PROLAPSE. UPON REVIEW OF HER MEDICAL RECORDS, THERE WAS NO INDICATION THAT BLADDER SUPPORT HAD BEEN PERFORMED, AND SHE WAS MISDIAGNOSED WITH GENITAL HERPES. THE PHYSICIAN HAD SINCE RELOCATED, WHICH MADE FOLLOW-UP BECAME IMPOSSIBLE, AND THE REFERRING NURSE PRACTITIONER PROVIDED NO VIABLE SOLUTIONS. THE PATIENT REPORTED THE RESPONSE TO HER DISTRESS WAS DISMISSIVE, AND SHE LEFT THE OFFICE EMOTIONALLY SHAKEN AND UNSUPPORTED. SHE WAS REFERRED TO A UROGYNECOLOGIST, AND AFTER A SIX-WEEK WAIT, SHE UNDERWENT A SURGICAL PROCEDURE IN (B)(6) 2016. DURING THIS SURGERY, A XENFORM MESH WAS IMPLANTED. IT WAS NOTED THAT THE SURGERY WAS INEFFECTIVE. BEFORE SHE COULD COMPLETELY RECOVER, HER BLADDER PROLAPSED AGAIN. SUBSEQUENTLY, SHE LEARNED THAT HER BLADDER WAS NOT LIFTED AT ALL, INSTEAD, THE PHYSICIAN LIFTED HER RECTUM, IN AN ATTEMPT TO INDIRECTLY SUPPORT THE BLADDER. AFTER FIVE MONTHS AND SIX-WEEKS-POST-OPERATION RECOVERY, ANOTHER SURGERY WAS SCHEDULED. IN (B)(6) 2017, THE PATIENT NOTED TISSUE FALLING THROUGH HER VAGINA AGAIN. DURING HER FOLLOW-UP EXAMINATION, NO ABNORMALITY WAS FOUND; HOWEVER, SHE WAS INSTRUCTED TO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Prolapse; Scar Tissue; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Weight Changes

  MAUDE report 22101308 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 3005099803-2023-02693 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPYSLON Y-MESH AND XENFORM GRAFT DEVICE WERE IMPLANTED INTO THE PATIENT DURING A SACROCOLPOPEXY-DAVINCI-SHD, EXTENSIVE LAPAROSCOPIC LYSIS OF ADHESIONS, RIGHT URETEROLYSIS, EXPLORATORY LAPAROTOMY, CYSTOTOMY REPAIR, AND XENFORM GRAFT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015, FOR THE TREATMENT OF VAGINAL PROLAPSE, STRESS URINARY INCONTINENCE, AND DYSPAREUNIA. EXTENSIVE ADHESIONS OF THE SIGMOID, COLON, AND SMALL BOWEL TO THE BLADDER AND PELVIC SIDEWALLS WERE NOTED DURING SURGERY. A CYSTOTOMY WAS OBSERVED IN THE SUPRATRIGONAL REGION THAT WAS REPAIRED, AS WELL AS BRISK OUTFLOW OF CLEAR URINE FROM BOTH URETERS. THERE WERE NO COMPLICATIONS THROUGHOUT THE PROCEDURE. FURTHERMORE, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17015200 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM GRAFT DEVICE WAS IMPLANTED INTO THE PATIENT DURING A LAPAROSCOPY, LYSIS OF ADHESIONS, LAPAROSCOPIC CULDOPLASTY - MOSCHCOWITZ AND MIDLINE CYSTOCELE REPAIR WITH BILATERAL PARAVAGINAL REPAIR AND PLACEMENT OF A XENFORM GRAFT PROCEDURES PERFORMED ON JUNE 1, 2015 FOR THE TREATMENT OF PELVIC PAIN, PELVIC ADHESIONS, VAGINAL APICAL PROLAPSE AND CYSTOCELE MIDLINE AND LATERAL WITH URINARY RETENTION. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS.AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16718871 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM GRAFT DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TOTAL VAGINAL HYSTERECTOMY WITH ANTERIOR AND POSTERIOR COLPORRHAPHY AND PUBOVAGINAL SLING PLACEMENT PROCEDURES PERFORMED ON (B)(6), 2012, FOR THE TREATMENT OF CYSTOCELE, RECTOCELE, STRESS INCONTINENCE, AND DYSFUNCTIONAL UTERINE BLEEDING (DUB). THROUGHOUT THE SURGERY, NO COMPLICATIONS WERE REPORTED. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16710116 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR VAGINAL WALL REPAIR WITH BIOLOGICAL SLING PROCEDURE PERFORMED ON (B)(6) 2015 TO TREAT CYSTOCELE AND URETHROCELE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16691099 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM GRAFT WAS IMPLANTED DURING SLING OPERATION FOR INCONTINENCE, TRANSVAGINAL REPAIR OF CYSTOCELE, TRANSVAGINAL COLPOPEXY USING SACROSPINOUS FIXATION, PARTIAL VAGINECTOMY/EXCISION OF VAGINAL MUCOSA MASS, CYSTOSCOPY, AND REMOVAL OF PREVIOUS PROLENE MESH SLING MATERIAL PROCEDURE PERFORMED ON (B)(6) 2016, TO TREAT A PATIENT WITH CYSTOCELE, VAGINAL PROLAPSE, VAGINAL MUCOSAL LESION, URINARY STRESS INCONTINENCE, AND DYSPAREUNIA. IT WAS NOTED THAT THERE WAS HYPERTROPHIED VAGINAL MUCOSA AROUND THE REGION OF THE BLADDER NECK THAT APPEARED SUSPICIOUS. IT WAS EXCISED AND REPAIRED. THERE WERE NO PATIENT COMPLICATIONS DURING THE IMPLANT PROCEDURE. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN SATISFACTORY STATUS. A VAGINAL PACKING WAS INSERTED. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15815330 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE THIRD OF THREE DEVICES IMPLANTED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS DIAGNOSED WITH LATERAL CYSTOCELE, POST HYSTERECTOMY VAGINAL VAULT PROLAPSE, ENTEROCELE, RECTOCELE, URODYNAMIC STRESS URINARY INCONTINENCE, WEAK RECTOVAGINAL TISSUE AND OVARIAN ADHESIONS. ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH UPSYLON Y-MESH, ADVANTAGE FIT SYSTEM AND XENFORM DEVICES DURING A BILATERAL SALPINGO-OOPHORECTOMY, SACROCOLPOPEXY, ENTEROCELE REPAIR, BILATERAL PARAVAGINAL REPAIR, TENSION-FREE VAGINAL TAPE, URETHROSCOPY, RECTOCELE REPAIR, ANAL SPHINCTEROPLASTY, PLACEMENT OF XENO GRAFT DUE TO WEAK AND, FRIABLE PELVIC FLOOR TISSUE, LYSIS OF ADHESIONS (LOA), VAGINAL PACKING DUE TO EXTENSIVE DISSECTION AND OOZING AND FOLEY PLACEMENT PROCEDURE. ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF STRESS URINARY INCONTINENCE SLING (ADVANTAGE), URETHROLYSIS AND URETHROCYSTOSCOPY PROCEDURE DUE TO IRRITATIVE OBSTRUCTIVE SYMPTOMS WITH URINARY RETENTION. DURING URETHROLYSIS, THE PHYSICIAN REMOVED THE SCAR TISSUE SURROUNDING THE URETHRA AND MOBILIZED THE URETHRA THROUGH LYSIS OF ADHESIONS TO FREE IT UP COMPLET

  Patient problems: Micturition Urgency; Obstruction/Occlusion; Scar Tissue; Urinary Retention

  MAUDE report 11408953 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI), AND WAS IMPLANTED WITH A XENFORM DEVICE AND A NON-BSC DEVICE ON (B)(6) 2017. AS REPORTED BY THE PATIENT'S ATTORNEY, ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION SURGERY RELATED TO THE XENFORM DEVICE AND A NON-BSC DEVICE DUE TO THE ASSOCIATED POST-OPERATIVE DIAGNOSIS OF VAGINAL FOREIGN BODY DERMIS IN THE ANTERIOR VAGINA, IN THE POSTERIOR VAGINA, AND SUBURETHRAL. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: Erosion; No Code Available

  MAUDE report 9834259 ↗