Advantage Fit Ultra System M0068502160Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00191506007669), received between Jan 13, 2022 and Mar 25, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT AN ADVANTAGE FIT ULTRA SYSTEM DEVICE UPON RECEIPT WAS REPORTED AS DAMAGED. THE HEALTHCARE FACILITY PROVIDED PHOTOGRAPHIC EVIDENCE SHOWING DENTS ON THE DEVICE PACKAGING, ALONG WITH CRACKING AND BREAKAGE OF THE PLASTIC BLISTER TRAY PRIOR TO USE. NO PATIENT INVOLVEMENT WAS REPORTED, AND THE DEVICE WAS NOT USED IN A CLINICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693981 ↗
• MalfunctionJan 9, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING A MID-URETHRAL SLING PROCEDURE USING AN ADVANTAGE FIT ULTRA SYSTEM, THE DEVICE WAS DIFFICULT TO ADVANCE CAUSING THE BLUE SHEATH TO SLIP BACK ON TROCAR. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030438 ↗
• MalfunctionJan 9, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION, THE PACKAGING SEAL WAS COMPROMISED DUE TO AN INCOMPLETELY GLUED EDGE. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028400 ↗
• MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PROCEDURE USING AN ADVANTAGE FIT ULTRA DEVICE, THE MESH AND SHEATH WERE DISCONNECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501263 ↗
• MalfunctionOct 28, 2025Unsealed Device Packaging; Material Deformation; Unsealed Device Packaging; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION, IT WAS OBSERVED THAT THE DEVICE BOX WAS SLIGHTLY DAMAGED. UPON OPENING, THE STERILE PACKAGE WAS FOUND TO BE PARTIALLY UNSEALED, AND THE DEVICE ITSELF APPEARED SLIGHTLY DENTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408067 ↗
• MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STRESS URINARY INCONTINENCE SLING PROCEDURE USING THE ADVANTAGE FIT ULTRA SYSTEM DEVICE, THE MESH DETACHED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080436 ↗
• MalfunctionApr 30, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A MID-URETHRAL SLING AND CYSTOSCOPY PROCEDURE USING AN ADVANTAGE FIT ULTRA SYSTEM, THE DEVICE DID NOT FUNCTION CORRECTLY WHEN INSERTED INTO THE PATIENT. ANOTHER ADVANTAGE FIT ULTRA SYSTEM DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT ONE OF THE DILATORS HAD SEPARATED FROM THE SLEEVE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938986 ↗
• MalfunctionSep 20, 2024Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PROCEDURE USING AN ADVANTAGE FIT ULTRA DEVICE, THE PHYSICIAN FELT A TEAR IN THE SLING MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266597 ↗
• InjuryMar 21, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT ULTRA SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2022 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. DURING THE PROCEDURE, THE DEVICE WENT THROUGH THE PATIENT'S BLADDER ON THE SECOND PASS. WHEN THE SURGEON TOOK THE DEVICE OUT FROM THE PATIENT, THE NEEDLE WAS NOTED TO BE WARPED/BENT. THE PROCEDURE WAS COMPETED USING THE SAME DEVICE. HOWEVER, THERE IS NO INFORMATION REGARDING THE TREATMENT PERFORMED TO ADDRESS THE BLADDER PERFORATION.

  Patient problems: Perforation

  MAUDE report 13839162 ↗
• InjuryJan 13, 2022Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON NOVEMBER 18, 2021, AN ADVANTAGE FIT ULTRA SYSTEM DEVICE WAS USED DURING A BLADDER SLING PLACEMENT THE PHYSICIAN HAD DIFFICULTY REMOVING THE SLEEVES OF THE ADVANTAGE FIT ULTRA DEVICE DURING THE PROCEDURE WHICH RESULTED IN THE MESH BEING OVER TENSIONED. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT BEGAN EXPERIENCING URINARY RETENTION. IN THE PHYSICIAN'S ASSESSMENT, THE OVER TENSIONING OF THE MESH COULD HAVE CONTRIBUTED TO THE PATIENT'S SYMPTOMS. THE PATIENT WAS CATHETERIZED FOR FOUR WEEKS UNTIL THE SYMPTOMS RESOLVED. THE PATIENT WILL BE MONITORED AND IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Urinary Retention

  MAUDE report 13254292 ↗