AdVance XPRecalls & reported problems across all models

We found 2 models of AdVance XP by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2018 and Sep 16, 2026 — classified as 34 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. 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

Most reported AdVance XP problems

AdVance XP models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AdVance™ XP 720163-01

  Mesh, surgical, for stress urinary incontinence, male
  51 reports
• AdVance™ XP 720163-03

  Mesh, surgical, for stress urinary incontinence, male
  7 reports

Recent AdVance XP adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH A SLING DEVICE HAD RADIATION THERAPY PERFORMED IMMEDIATELY FOLLOWING THEIR SLING IMPLANT SURGERY IN (B)(6). THE PATIENT THEN EXPERIENCED RECURRING INCONTINENCE IN JANUARY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH AN ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT DEVICE WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 24747176 ↗
• MalfunctionMar 9, 2026Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS ADVANCE XP SLING PROCEDURE, THE PHYSICIAN STATED THAT THE TROCARS WERE INSERTED WITHOUT ISSUE AND THE SLING BODY WAS POSITIONED CORRECTLY AGAINST THE URETHRA. WHILE ATTEMPTING TO REMOVE THE PLASTIC PROTECTIVE SLEEVE, REMOVAL ON ONE SIDE WAS DIFFICULT AND THE CONTRALATERAL SIDE PRESENTED SIGNIFICANT DIFFICULTY. DURING THIS PROCESS, THE PROTECTIVE PLASTIC SLEEVE AND TYVEK PAPER BROKE, AND FRAGMENTS REMAINED IN THE PATIENT. AS A TROUBLESHOOTING MEASURE, THE SURGEON DIVIDED THE SLING ARM FROM THE SLING BODY THROUGH THE PERINEAL INCISION AND ATTEMPTED TO REMOVE THE SLING ARM FROM THE GROIN INCISION WITH THE EXPECTATION THAT THE PLASTIC SHEATH AND TYVEK PAPER WOULD BE REMOVED; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL. THE PROCEDURE WAS SUBSEQUENTLY ABANDONED, AND THE SURGEON DID NOT DEEM IT SAFE TO PROCEED WITH PASSING ANOTHER SLING ARM OR TROCAR ON THE AFFECTED SIDE. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS OF INFECTION FOLLOWING THE PROCEDURE. THE ISSUE WAS NOT PRESENT UPON OPENING THE PACKAGE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCEL

  Patient problems: Foreign Body In Patient

  MAUDE report 24553258 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE MESH OF THIS ADVANCE XP SLING BROKE DURING ATTEMPTED PLACEMENT; THE PROCEDURE WAS DISCONTINUED. A SECOND PROCEDURE WAS PLANNED TO REATTEMPT IMPLANT OF A SLING. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464330 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THIS SLING, ONE OF THE ARMS BECAME COMPLETELY DISLODGED FROM THE REST OF THE SLING, PREVENTING PROPER TENSIONING AND CORRECT PLACEMENT. AS A RESULT, THE DEVICE WAS REMOVED, AND THE PATIENT WAS RESCHEDULED FOR ANOTHER PROCEDURE AS NO BACKUP SLING WAS AVAILABLE. A FEW DAYS LATER, THE PATIENT CAME BACK AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383546 ↗
• 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 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HE FOLEY CATHETER USED DID NOT REACHED THE VESICAL SPACE WHEN IT WAS INSERTED INITIALLY, AND THE BALLOON DILATED SPECIFICALLY THE BULBAR URETHRA. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE SINCE URETHRA WAS AFFECTED, AND A BLADDER NECK NARROWNESS WAS DETECTED TOO. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699402 ↗
• 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 ↗
• InjuryFeb 13, 2025Stretched; Defective Device; Stretched; Defective Device

  IT WAS REPORTED THAT DURING THE SLING IMPLANTATION PROCEDURE FOR INCONTINENCE, THE LIGAMENTS STRETCHED AND BROKE WHEN THE ENDS WERE TIGHTENED. THE HOOKS EVEN POKED OUT OF THE PUNCTURE SITE IN THE GROIN. THE PROCEDURE WAS FINALLY COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Incontinence

  MAUDE report 21381690 ↗
• 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 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMINISTERED WITH LOCAL ANESTHESIA FOR AMS XP SLING IMPLANT ORIGINAL SURGERY TO TREAT INCONTINENCE. HOWEVER, THE PHYSICIAN DISSECTED PAST THE SPONGIOSUM AND WAS TOO CLOSE TO THE URETHRA AND DID NOT WANT TO PLACE MESH TOO CLOSE TO THE DISSECTED AREA. THE PHYSICIAN DECIDED TO CANCEL THE SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17405792 ↗
• InjuryNov 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SLING IMPLANT PROCEDURE A PART OF THE PROTECTIVE SHEATHS BROKE AT THE BASE. A PART OF THE SHEATH WAS NOT POSSIBLE TO BE REMOVED. THE ORIGINAL SLING WAS SUCCESSFULLY IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS SEEN DURING THE PROCEDURE OR THE POST OPERATIVE FOLLOW UP APPOINTMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15817563 ↗

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