Xenform™ M0068302450Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729773764), received between May 17, 2017 and Jun 2, 2023 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES IMPLANTED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBERS 3005099803-2023-02917 FOR THE SECOND XENFORM DEVICE AND 3005099803-2023-02918 FOR THE OBTRYX DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A VAGINAL HYSTERECTOMY WITH ANTERIOR AND POSTERIOR COLPORRHAPHY + TRANSOBTURATOR MID-URETHRAL SLING WITH CYSTOSCOPY + INTRAARCUS GRAFT + INTRASPINOUS GRAFT PROCEDURE PERFORMED ON (B)(6) 2011 DUE TO SYMPTOMATIC PELVIC RELAXATION: UTERINE PROCIDENTIA, THIRD DEGREE CYSTOURETHROCELE, THIRD DEGREE RECTOCELE AND MIXED URINARY INCONTINENCE. THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17050382 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES IMPLANTED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2023-02916 FOR THE FIRST XENFORM DEVICE AND 3005099803-2023-02918 FOR THE OBTRYX DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A VAGINAL HYSTERECTOMY WITH ANTERIOR AND POSTERIOR COLPORRHAPHY + TRANSOBTURATOR MID-URETHRAL SLING WITH CYSTOSCOPY + INTRAARCUS GRAFT + INTRASPINOUS GRAFT PROCEDURE PERFORMED ON (B)(6) 2011 DUE TO SYMPTOMATIC PELVIC RELAXATION: UTERINE PROCIDENTIA, THIRD DEGREE CYSTOURETHROCELE, THIRD DEGREE RECTOCELE AND MIXED URINARY INCONTINENCE. THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17050380 ↗
• InjuryApr 17, 2023Adverse 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 USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 3005099803-2023-01849 AND 3005099803-2023-01850 FOR THE ASSOCIATED DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM AND XENFORM GRAFT DEVICES WERE IMPLANTED INTO THE PATIENT DURING A MID-URETHRAL SLING OPERATION FOR STRESS INCONTINENCE, ANTERIOR AND POSTERIOR COLPORRHAPHY WITH REPAIR OF ENTEROCELE, INSERTION OF A GRAFT, VAGINAL COLPOPEXY, HYSTEROSCOPY WITH POLYPECTOMY, AND DILATATION AND CURETTAGE PROCEDURES PERFORMED ON (B)(6) 2013, FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE, CYSTOCELE, RECTOCELE, ENTEROCELE, AND ENDOMETRIAL POLYPS, AND GENUINE STRESS URINARY INCONTINENCE. THE PATIENT HAD THIRD-DEGREE PROLAPSE OF HER UTERUS, BLADDER, AND RECTUM, AS WELL AS A THIRD-DEGREE POSTERIOR DEFECT THAT WAS A COMBINED RECTOCELE AND ENTEROCELE, WHICH WERE DISCOVERED DURING THE PROCEDURE. SHE HAD A 2 CM POLYP THAT WAS ARISING FROM THE ANTERIOR UTERINE WALL AND APPEARED TO BE BENIGN. HER UTERUS HAD PROLAPSED PAST THE HYMENAL RING. FURTHERMORE, NO PATIENT COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. THE PROCEDURE WAS WELL TOLERATED

  Patient problems: Insufficient Information

  MAUDE report 16755939 ↗
• InjuryApr 17, 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 THREE DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 3005099803-2023-01849 AND 3005099803-2023-01854 FOR THE ASSOCIATED DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM AND XENFORM GRAFT DEVICES WERE IMPLANTED INTO THE PATIENT DURING A MID-URETHRAL SLING OPERATION FOR STRESS INCONTINENCE, ANTERIOR AND POSTERIOR COLPORRHAPHY WITH REPAIR OF ENTEROCELE, INSERTION OF A GRAFT, VAGINAL COLPOPEXY, HYSTEROSCOPY WITH POLYPECTOMY, AND DILATATION AND CURETTAGE PROCEDURES PERFORMED ON (B)(6) 2013, FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE, CYSTOCELE, RECTOCELE, ENTEROCELE, AND ENDOMETRIAL POLYPS, AND GENUINE STRESS URINARY INCONTINENCE. THE PATIENT HAD THIRD-DEGREE PROLAPSE OF HER UTERUS, BLADDER, AND RECTUM, AS WELL AS A THIRD-DEGREE POSTERIOR DEFECT THAT WAS A COMBINED RECTOCELE AND ENTEROCELE, WHICH WERE DISCOVERED DURING THE PROCEDURE. SHE HAD A 2 CM POLYP THAT WAS ARISING FROM THE ANTERIOR UTERINE WALL AND APPEARED TO BE BENIGN. HER UTERUS HAD PROLAPSED PAST THE HYMENAL RING. FURTHERMORE, NO PATIENT COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. THE PROCEDURE WAS WELL TOLERATE

  Patient problems: Insufficient Information

  MAUDE report 16755873 ↗
• InjuryApr 17, 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 VAGINAL-PARAVAGINAL ANTERIOR REPAIR, EXCISION OF EXPOSED VAGINAL PROLENE MESH, AND CYSTOSCOPY PROCEDURES PERFORMED ON (B)(6) 2016, FOR THE TREATMENT OF RECURRENT CYSTOCELE AND EXPOSED VAGINAL MESH. A CYSTOCELE OF THE FIRST TO SECOND DEGREE WAS OBSERVED DURING SURGERY, AND A PATCH OF EXPOSED PROLENE MESH IS SEEN AT THE APEX OF THE VAGINA IN THE MIDLINE. FURTHERMORE, THERE WAS NO EVIDENCE OF BLADDER TRAUMA FROM THE PASSAGE OF SUTURES OR MESH INTO THE BLADDER OR URETHRA AT THE CONCLUSION OF THE PROCEDURE. THE PROCEDURE WAS WELL TOLERATED BY THE PATIENT, WHO WAS IN A STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY AS A RESULT OF THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16751434 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 3005099803-2023-01481 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX SYSTEM - CURVED AND XENFORM GRAFT DEVICE WERE IMPLANTED INTO THE PATIENT DURING A VAGINAL HYSTERECTOMY WITH ANTERIOR AND POSTERIOR COLPORRHAPHY, TRANSOBTURATOR MID-URETHRAL SLING PLACEMENT, AND INTERARCUS GRAFT OR INTRASPINOUS GRAFT PROCEDURE PERFORMED ON (B)(6) 2011 FOR THE TREATMENT OF SECOND- TO THIRD-DEGREE UTERINE PROLAPSE, THIRD-DEGREE CYSTOURETHROCELE, SECOND- TO-THIRD-DEGREE RECTOCELE, AND STRESS INCONTINENCE AND STRESS INCONTINENCE. THROUGHOUT THE SURGERY, NO COMPLICATIONS WERE REPORTED. IN ADDITION, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY AS A RESULT OF THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16640526 ↗
• InjuryFeb 3, 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 TISSUE REPAIR MATRIX DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR REPAIR, PLACEMENT OF INTERPOSITION GRAFT (XENFORM), VAULT SUSPENSION AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016, FOR THE TREATMENT OF RECTOCELE, VAGINAL VAULT PROLAPSE AND INCOMPLETE BLADDER EMPTYING. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16292702 ↗
• InjuryAug 16, 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 MATERIALS WAS IMPLANTED INTO THE PATIENT DURING A PARAVAGINAL REPAIR WITH GRAFT, EXCISION AND REVISION OF VAGINAL MESH (7CM TOTAL VAGINAL MESH WOUND, MODIFIER 22), POSTERIOR REPAIR AND PERINEORRHAPHY, CYSTOURETHROSCOPY, EXCISION OF LABIAL CYST AND USE OF XENOGRAFT PROCEDURE PERFORMED ON (B)(6) 2018 FOR THE TREATMENT OF PELVIC PAIN, VAGINAL MESH EXPOSURE, CYSTOCELE, URGE URINARY INCONTINENCE, LEFT LABIAL CYST, RECTOCELE AND WEAKENED PELVIC TISSUE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15237839 ↗
• InjuryNov 25, 2020Adverse 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 TISSUE REPAIR MATRIX WAS IMPLANTED INTO THE PATIENT DURING A PROLAPSE PROCEDURE PERFORMED ON (B)(6) 2016 FOR THE TREATMENT OF PROLAPSE. ACCORDING TO THE PATIENT, AFTER THE PROCEDURE, THE PATIENT HAS EXPERIENCED LARGE SWELLING/EDEMA THAT IS OBVIOUS IN A LARGE SQUARE SHAPE AROUND THE PATIENT'S TAILBONE REGION/LOWER SPINE. REPORTEDLY, THE PATIENT'S TAILBONE WOULD ACHE AND STING AFTER SITTING FOR LONGER THAN 30 MINUTES. IN ADDITION, THE PATIENT IS UNABLE TO LIFT MORE THAN 3KG AGAIN AND IS ONLY ABLE TO SLEEP ON BACK. SUBSEQUENTLY, THE PATIENT TAKES MERSYNDAL FORTE OR MERSYNDAL CAPETS TO HELP WITH PAIN IN THE NIGHTTIME AND IS ALSO ON ANTIDEPRESSANTS, TRIALLED LYRICA FOR PAIN, AND GABAPENTIN AND BETA BLOCKERS PLUS MOBIC AND SOMAC TO HELP WITH PAIN AND SWELLING. THE PATIENT ALSO REGULARLY SEES A CLINICAL THERAPIST SINCE HER PROLAPSE SURGERY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: Disability; Edema; Pain; Swelling

  MAUDE report 10900265 ↗
• InjuryMar 19, 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 IMPLANTED WITH A XENFORM DEVICE FOR POSTERIOR REPAIR ON (B)(6) 2011. AS REPORTED BY THE PATIENT'S ATTORNEY, ON (B)(6) 2011, THE PATIENT EXPERIENCED RECURRENT RECTOCELE, AND WAS THEN IMPLANTED WITH A REPLIFORM DEVICE FOR POSTERIOR REPAIR. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: No Code Available; Prolapse

  MAUDE report 9857316 ↗
• InjuryMar 19, 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 CYSTOCELE AND WAS THEN IMPLANTED WITH A XENFORM DEVICE FOR PROLAPSE REPAIR ON (B)(6) 2015. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT UNDERWENT A REVISION SURGERY RELATED TO THE XENFORM DEVICE AND PREVIOUSLY-IMPLANTED NON-BSC MESH DEVICE(S) ON (B)(6) 2018 DUE TO A DIAGNOSIS OF EXPOSURE OF VAGINAL MESH WITH GRANULATION. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: Erosion; Injury; No Code Available

  MAUDE report 9852916 ↗
• InjurySep 24, 2019Adverse 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 WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED SENSATION OF BULGE RELATED TO THE POSTERIOR AND APICAL VAGINAL COMPARTMENTS ON (B)(6) 2015. A PESSARY WAS PLACED TO TREAT THE EVENT ON (B)(6) 2015 AND (B)(6) 2015, AND WAS SUBSEQUENTLY REMOVED ON (B)(6) 2015 AND (B)(6) 2015. ON (B)(6) 2015, THE PATIENT UNDERWENT RETREATMENT FOR PROLAPSE INCLUDING LAPAROSCOPIC TOTAL HYSTERECTOMY, APICAL VAULT SUSPENSION, RECTOCELE REPAIR, AND ENTEROCELE REPAIR WITH XENFORM GRAFT. DURING THE PROCEDURE IT WAS NOTED THAT THERE WERE SEVERE LEFT HEMIPELVIC ADHESIONS ENCOMPASSING THE LEFT ADNEXAL STRICTURES INCLUDING OVARY AND TUBE, CREATING SIGNIFICANT SCAR TISSUE THAT THE LEFT OVARY AND TUBE WERE BARELY VISIBLE. THE EVENT RESOLVED ON (B)(6) 2015 AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. THE EVENT WAS ASSESSED AS PROBABLY RELATED TO THE INDEX PROCEDURE, AND PROBABLY RELATED TO THE STUDY DEVICE.

  Patient problems: Adhesion(s); No Code Available; Prolapse; Scar Tissue

  MAUDE report 9112308 ↗
• InjuryOct 12, 2018Adverse 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 WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING APICAL VAULT SUSPENSION AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT EXPERIENCED CYSTITIS. SHE WAS TREATED WITH MACROBID AND THE EVENT RESOLVED WITH NO SEQUELAE ON (B)(6) 2015.

  Patient problems: Inflammation

  MAUDE report 7960835 ↗
• InjurySep 5, 2018Adverse 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 DURING A PELVIC FLOOR REPAIR PROCEDURE WITH XENFORM INCLUDING VAGINAL-APPROACH HYSTEROPEXY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE PATIENT PRESENTED WITH BLADDER OUTLET OBSTRUCTION AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016. SHE UNDERWENT A REVISION PROLAPSE SURGERY AND THE DEVICE WAS COMPLETELY REMOVED FROM THE POSTERIOR VAGINAL WALL. SHE WAS THEN DISCHARGED ON (B)(6) 2016 AND THE EVENT OF OBSTRUCTION RESOLVED ON (B)(6) 2016.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Discomfort; Obstruction/Occlusion; Pain; Unspecified Infection; Urinary Retention

  MAUDE report 7846961 ↗
• InjuryMay 17, 2017Adverse 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 TISSUE REPAIR MATRIX WAS USED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING VAGINAL APPROACH HYSTEROPEXY AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE PATIENT EXPERIENCED URINARY RETENTION. NO TREATMENT WAS GIVEN AND THE EVENT IS CURRENTLY RESOLVING.

  Patient problems: Urinary Retention

  MAUDE report 6571520 ↗