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Xenform™ M0068302410Recalls & reported problems

Boston Scientific Corporation · Soft Tissue Repair Matrix · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729775133), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 4, 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 WAS IMPLANTED DURING A REMOVAL OF IRRITATING AND EXPOSED SURGICAL MESH, DIVISION OF MESH ARMS, SUBURETHRAL SLING USING PRECISION TWIST AND XENOGRAFT ANTERIOR AND POSTERIOR COLPORRHAPHY PROCEDURES PERFORMED ON (B)(6) 2006 TO TREAT A PATIENT WITH RIGHT BUTTOCKS PAIN, ERODED SURGICAL MESH FROM PREVIOUS PROLIFT PROCEDURE (4X4 CM MINIMUM DIMENSIONS), ENCAPSULATED SURGICAL MESH, PERSISTENT URINARY INCONTINENCE, AND PELVIC RELAXATION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNSPECIFIED INJURY.

    Patient problems: Insufficient Information

    MAUDE report 15728395 ↗

Other Mesh, surgical devices

All Mesh, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.