XenformRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls
- 0
We found 4 models of Xenform by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between May 4, 2017 and May 28, 2025 — classified as 47 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Xenform problems
Device problems
- Adverse Event Without Identified Device or Use Problem47
Patient problems
- Insufficient Information16
- No Code Available8
- Pain8
- Prolapse7
- Unspecified Infection7
- Urinary Retention7
- Erosion4
- Scar Tissue4
Xenform models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Xenform™ M0068302470Mesh, surgical23 reports
- Xenform™ M0068302450Mesh, surgical15 reports
- Xenform™ M0068302430Mesh, surgical8 reports
- Xenform™ M0068302410Mesh, surgical1 report
Recent Xenform adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗InjuryMay 1, 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 ROBOTIC-ASSISTED LAPAROSCOPIC SACROCOLPOPEXY, LYSIS OF ADHESIONS, EXCISION OF EXPOSED MESH INTRAABDOMINALLY, REPAIR OF IMMEDIATELY RECOGNIZED RECTAL INJURY, PERITONEAL FLAP ADVANCEMENT AS AN INTERPOSING FLAP, AND PLACEMENT OF A BIOLOGIC INTERPOSING GRAFT FOR THE TREATMENT OF RECURRENT ENTEROCELE AND RECTOCELE STATUS POST-HISTORY OF TRANSVAGINAL SURGICAL PROCEDURE TO CORRECT PROLAPSE AND MESH EXPOSURE WITH ADHERENCE TO SMALL BOWEL INTRAABDOMINALLY PROCEDURES ON (B)(6) 2014. PRIOR TO PLACEMENT OF THE XENFORM, DURING POSTERIOR DISSECTION FOR THE PLACEMENT OF A NON-BSC Y-MESH, THE RECTAL WALL REPORTEDLY HAD A SMALL OPENING DURING THE DISSECTION PROCESS THAT WAS DETECTED RIGHT AWAY AND MEASURED LESS THAN 2 CM. A TWO-LAYER CLOSURE WAS THEN DECIDED TO PERFORM. A XENFORM WAS PLACED TO INTERPOSE BETWEEN THE ANTICIPATED PLACEMENT OF THE NON-BSC Y-MESH AND THE REPAIR OF THE RECTAL DEFECT. THE PATIENT TOLERATED THE PROCEDURE WELL; CONSEQUENTLY, SHE WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSP
Patient problems: Insufficient Information
MAUDE report 16850577 ↗InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
*NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSVAGINAL HYSTERECTOMY + BILATERAL SALPINGO - OOPHORECTOMY + POSTERIOR REPAIR WITH XENFORM MESH PROCEDURE PERFORMED ON (B)(6) 2010 FOR THE TREATMENT OF UTEROVAGINAL PROLAPSE, CYSTOCELE RECTOCELE, POSTMENOPAUSAL BLEEDING AND URINARY INCONTINENCE. FINDINGS SHOWED UTEROVAGINAL PROLAPSE WITH LARGE MID - PORTION RECTOCELE AND CENTRAL DEFECT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.
Patient problems: Insufficient Information
MAUDE report 16809953 ↗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 ↗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 ↗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 16, 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. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM AND XENFORM DEVICES WERE IMPLANTED INTO THE PATIENT DURING AN ANTERIOR COLPORRHAPHY, BILATERAL SS VAGINAL VAULT SUSPENSION/UTERINE SUSPENSION, RECTOCELE REPAIR, SLING REVISION, TENSION FREE VAGINAL TAPE SUBURETHRAL SLING WITH BS SYSTEM, PLACEMENT OF XENO GRAFT, ANAL SPHINCTEROPLASTY, BARTHOLIN CYSTECTOMY, SKIN BIOPSY, VAGINAL PACKING DUE TO EXTENSIVE DISSECTION AND OOZING. URETHRAL CYSTOSCOPY, FOLEY PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015 TO TREAT MIDLINE CYSTOCELE, UTERINE PROLAPSE, RECTOCELE, URODYNAMIC STRESS URINARY INCONTINENCE, URINARY FREQUENCY AND URGENCY, FECAL INCONTINENCE, WEAKENED PELVIC TISSUE. ON (B)(6) 2015, THE PATIENT HAD REVISION OF SLING, URETHROLYSIS AND URETHROCYSTOSCOPY DUE TO IRRITATIVE OBSTRUCTIVE SYMPTOMS WITH URINARY RETENTION. POSTOPERATIVE DIAGNOSE REPORTED NO OBVIOUS URETHRAL BLOCKAGE FROM THE SLING. THE SLING APPEARED TO BE IN DISTAL URETHRAL PORTION OF URETHRA. DURING THE PROCEDURE, THE SLING WAS COMPLETELY FREED OFF FROM ITS ATTACHMENT TO THE URETHRA AND SURROUNDING SCA
Patient problems: Scar Tissue; Urinary Retention
MAUDE report 16384653 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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