AdVance™ XP 720163-03Recalls & reported problems
Boston Scientific Corporation · Male Sling System · Class 2 · Implant
All models of AdVance XP (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00191506003999), received between Oct 31, 2024 and Sep 16, 2026 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Adverse Event Without Identified Device or Use Problem1
- Contamination /Decontamination Problem1
- Device Contaminated During Manufacture or Shipping1
- Device Damaged Prior to Use1
- Insufficient Device Problem Information1
- Mechanical Problem1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Urinary Retention2
- Burning Sensation1
- Incontinence1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this sling experienced urinary retention. The patient was catheterized. After allowing for some time for improvement of symptoms, the physician took the patient back to the Operating Room (OR) to cut one arm of the sling to reduce its tension. No additional information was provided.
Patient problems: Urinary Retention
MAUDE report 50792877 ↗InjuryJan 20, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WITH AN ADVANCE SLING EXPERIENCED URINARY RETENTION. THE PATIENT STATED THAT A CATHETER WAS PLACED FOLLOWING THE IMPLANT SURGERY, WHICH WAS LATER REMOVED DURING A POST-OPERATIVE VISIT. A SECOND CATHETER WAS PLACED AFTER THE PATIENT UNDERWENT A FOUR-HOUR FLUID INTAKE TEST (16/32 OZ) AND WAS UNABLE TO VOID. AN ULTRASOUND REVEALED THAT THE PATIENT WAS RETAINING 365 CC OF FLUID. THE SECOND CATHETER WAS SUBSEQUENTLY REMOVED, AND THE PATIENT WAS ABLE TO VOID; HOWEVER, HE IS NOW EXPERIENCING A WEAK STREAM, BURNING, AND PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Burning Sensation; Pain; Urinary Retention
MAUDE report 24125313 ↗InjuryAug 20, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AFTER THE PROCEDURE. CONCERNS WERE NOTED REGARDING THE SLING DEVICE, WHICH APPEARS TO BE SOMEWHAT LOOSE. WHEN THE PATIENT STANDS, THE WEIGHT DISTRIBUTION REPORTEDLY CAUSES A PROLAPSE INTO THE PERINEAL AREA. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 22856237 ↗InjuryApr 8, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE FOR URONARY INCONTINENCE, WHEN THE PHYSICIAN BEGAN TENSIONING SLING USING CONSERVATIVE TENSIONING PRESSURE, ONE OF THE FIXATION SUTURES POPPED. DOCTOR TENSIONED AGAIN AND THE LEFT SLING ARM RIPPED BETWEEN THE WIDEST PART OF THE SLING AND THE FIRST CHEVRON. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER SLING. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: Incontinence
MAUDE report 21800176 ↗MalfunctionMar 12, 2025Device Damaged Prior to Use; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Damaged Prior to Use; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem
IT WAS REPORTED THAT UPON INSPECTING THIS SLING AND ITS PACKAGING DURING THE IMPLANT PROCEDURE, THE SURGEON DETERMINED IT WAS CONTAMINATED, AND IT WAS NOT USED AS A RESULT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE SLING DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21586403 ↗MalfunctionNov 27, 2024Break; Break
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SLING ADVANCE XP CAME OFF OF THE TROCAR. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20790453 ↗MalfunctionOct 31, 2024Break; Break
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THIS SLING, THE SURGEON TENSIONED AND SLING TORE UNDER TENSION. THE BROKEN SLING WAS REMOVED, AND A NEW ONE WAS PLACED WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579373 ↗
Other Mesh, surgical, for stress urinary incontinence, male devices
- AdVance™ XP 720163-01Boston Scientific Corporation · Mesh, surgical, for stress urinary incontinence, male51 reports
- AdVance 720088-01American Medical Systems, Inc. · Mesh, Surgical, For Stress Urinary Incontinence, Male7 reports
- Virtue 50020Coloplast A/S · Mesh, surgical, for stress urinary incontinence, male4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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