AdVance™ XP 720163-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00878953005560), received between Jan 23, 2018 and Mar 31, 2026 — classified as 30 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 17, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE FOR THIS SLING, THE KIT OPENED WAS MISSING THE SLING. THE PROCEDURE WAS NOT ABLE TO BE PERFORMED WITHOUT THE DEVICE; THEREFORE, IT WAS RESCHEDULED. IT WAS INDICATED THAT THE PATIENT HAD ALREADY BEEN ADMINISTERED GENERAL ANESTHESIA WHEN THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR A CANCELLED PROCEDURE WITH THE PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813004 ↗
• InjuryAug 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A SLING ADVANCE XP IMPLANTED. DURING ONGOING USE OF THE SLING DEVICE THE PATIENT EXPERIENCED URINARY INCONTINENCE, WHICH NECESSITATED THE IMPLANT OF A NEW ARTIFICIAL URINARY SPHINCTER. THE EXACT CAUSE OF THE INCONTINENCE WAS NOT REPORTED BY THE MEDICAL FACILITY, BUT THEY STATED IT COULD HAVE BEEN THAT THE SLING SLIPPED OR THAT IT WAS NEVER FUNCTIONAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Urinary Incontinence

  MAUDE report 15237419 ↗
• MalfunctionApr 1, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A MALE SLING PROCEDURE, THE SHEET AND PAPER PROTECTING THE SLING ARMS CAME OFF SOONER THAN THE PHYSICIAN WANTED. THE PHYSICIAN TRIED TO TAPER THE MESH WITH THE SLING ARMS ALONE, BUT THE SLING WAS NOT ABLE TO ACHIEVE THE APPROPRIATE COAPTATION WHEN TIGHTENING THE SLING ARMS. THE SLING ARMS BEGAN STRETCHING AND UNRAVELING; THEREFORE, THE PHYSICIAN DECIDED TO REPLACE IT WITH A NEW SLING. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13973282 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT SURGERY OF THE ADVANCE XP SLING THE PHYSICIAN WAS TENSIONING THE DEVICE AND AN UNANTICIPATED BLEEDING OCCURRED. THE UNANTICIPATED BLEEDING WAS BELIEVED TO BE A RESULT OF TENSIONING THE SLING AND RUPTURING A VESSEL. THE PHYSICIAN USED A CLOTTING SPONGE TO CONTROL BLEEDING. THE QUICK CLOTTING SPONGES WERE LEFT INSIDE OF THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 13025082 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY INCONTINENCE DUE THE SLING DID NOT IMPROVE THE SPHINCTER CONTROL. THERE WAS NO DEVICE MALFUNCTION WITH THE SLING. AN ARTIFICIAL URINARY SPHINCTER (AUS) WAS IMPLANTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Urinary Incontinence

  MAUDE report 12894827 ↗
• InjuryNov 12, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN SLING ADVANCE XP IMPLANT SURGERY THE DEVICE DISCONNECTED FROM THE TROCAR WHEN PULLING THOUGH THE TISSUES. THE PHYSICIAN ATTEMPTED TO RECONNECT THE DEVICE BUT THE MATERIAL GOT FLARED AND IT DID NOT FASTEN, BECOMING UNUSABLE, DESPITE SEVERAL APPROACHES WITHOUT SUCCESS. THE PATIENT WAS ANESTHETIZED FOR TWO HOURS DUE TO THE ISSUES WHILE WAITING FOR A SECOND SLING ADVANCE XP TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802335 ↗
• MalfunctionSep 8, 2021Break; Break

  IT WAS REPORTED THAT DURING INSERTION THE MESH FROM SLING RIPPED WHEN TRYING TO APPLY TENSION. IT WAS STATED THAT EXCESSIVE FORCE WAS NOT THE REASON OF THE RUPTURE. THERE WAS NO PATIENT COMPLICATIONS AND THE PROCEDURE COMPLETED WITH A BACK UP OF THE SAME PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12438390 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A SLING DEVICE HAD AN UNCHANGED LEVEL OF INCONTINENCE SINCE THE DEVICE WAS IMPLANTED. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH AN ARTIFICIAL URINARY SPHINCTER (AUS) WAS IMPLANTED TO STOP THE LEAKING. THE PATIENT WAS FINE FOLLOWING THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154055 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN ADVANCE XP SLING BUT DURING THE ONGOING USE PERIOD IT WAS DETERMINED THAT THE PATIENT WAS STILL SUFFERING FROM INCONTINENCE. THERE WERE NO DEVICE ISSUES HOWEVER IT WAS DECIDED THAT AN ARTIFICIAL URINARY SPHINCTER (AUS) WOULD BE THE BEST OPTION FOR THE PATIENT. A REVISION SURGERY WAS PERFORMED AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Urinary Incontinence

  MAUDE report 12046242 ↗
• InjuryJun 3, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ONE DAY POSTOPERATIVE THE PATIENT EXPERIENCED URINARY RETENTION WITH A SLING DEVICE. IT WAS INDICATED THAT THE PATIENT WAS UNABLE TO VOID AT ALL; THEREFORE, THE PATIENT WAS CATHETERIZED FOR AN ADDITIONAL WEEK. A MONTH LATER THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH THE DEVICE. THE PHYSICIAN SUSPECTED THE SLING MIGHT HAVE SLIPPED BUT THERE WERE NO DEVICE MALFUNCTIONS WITH THE SLING. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH A NEW ARTIFICIAL URINARY SPHINCTER (AUS) WAS IMPLANTED. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Urinary Incontinence; Urinary Retention

  MAUDE report 11929393 ↗
• InjuryMar 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF DISCOMFORT, PAIN, AND A BURNING SENSATION WITH THE ADVANCE XP SLING. THE PHYSICIAN INDICATED HE FELT THE SLING WAS CAUSING IRRITATION TO THE URETHRA AND THE PATIENT WAS STILL LEAKING WITH URGENCY TO URINATE. THE PHYSICIAN REVISED THE SLING BY CUTTING THE LATERAL ENDS AND RELEASING THE SLING. AN ARTIFICIAL URINARY SPHINCTER WAS ALSO IMPLANTED. THE PATIENT WAS EXPECTED TO FULLY RECOVER FOLLOWING THE REVISION SURGERY.

  Patient problems: Discomfort; Micturition Urgency; Pain; Skin Inflammation/ Irritation; Urinary Incontinence

  MAUDE report 11391800 ↗
• InjuryFeb 25, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE TO IMPLANT THIS SLING DEVICE, THE RIGHT BRANCH OF THE STRIP BROKE APPROXIMATELY 1 CM FROM THE FLARED PORTION. THE REMAINING END OF THE STRIP WAS ABLE TO BE SECURED SATISFACTORILY. IT WAS STATED THE BROKEN PORTION OF THE SLING WAS NOT PRESERVED; IT IS UNCLEAR IF ANY PORTION REMAINS UNSECURED IN THE PATIENT. THERE WERE NO IRREGULARITIES OBSERVED WITH THE SLING WHEN INSPECTED UPON REMOVAL FROM THE BOX. THERE WERE NO REPORTED PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382056 ↗
• InjuryNov 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN ADVANCE XP SLING IMPLANTED. FOLLOWING THE IMPLANT SURGERY THE PATIENT'S INCONTINENCE IMPROVED BUT HE STILL CONTINUED TO EXPERIENCE SOME URINARY INCONTINENCE. IT IS NOT BELIEVED THAT THERE WERE ANY DEVICE ISSUES OR MALFUNCTIONS THAT CONTRIBUTED TO THE CONTINUED INCONTINENCE. THE PATIENT WAS THEN IMPLANTED WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) DEVICE.

  Patient problems: Incontinence

  MAUDE report 10817827 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SLING IMPLANT PROCEDURE THE FIRST HELICAL NEEDLE WAS SUCCESSFULLY PASSED AND CONNECTED TO THE SLING. THE SECOND HELICAL NEEDLE PERFORATED THE URETHRA AND WAS CONNECTED TO THE DEVICE. WHEN THE SLING WAS PULLED THROUGH, THE URETHRAL INJURY WAS NOTICED. THE PHYSICIAN REMOVED THE ENTIRE DEVICE AND REPAIRED THE PERFORATION. THE PROCEDURE WAS THEN ABORTED DUE TO THIS INJURY.

  Patient problems: Perforation

  MAUDE report 10695581 ↗
• InjuryOct 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN ADVANCE XP IMPLANTED ON (B)(6) 2019. A NEW ARTIFICIAL URINARY SPHINCTER CONSISTING OF A CUFF, PUMP, AND BALLOON WAS IMPLANTED ON (B)(6) 2020 AS THE LEVEL OF INCONTINENCE HAD NOT CHANGED. THE PATIENT WAS WELL AND RECOVERING.

  Patient problems: Incontinence

  MAUDE report 10652477 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN ADVANCE XP SLING ON (B)(6) 2020. THE PATIENT'S INCONTINENCE HAD IMPROVED BUT THE PATIENT WANTED TO BE COMPLETELY DRY SO THEY DECIDED TO IMPLANT AN AUS DEVICE. THERE WERE NO DEVICE ISSUES WITH THE SLING THAT RESULTED IN THE PATIENT'S CONTINUED INCONTINENCE. THE PATIENT WAS NOT A GOOD CANDIDATE FOR THE SLING BECAUSE OF HIS LEVEL OF INCONTINENCE. FOLLOWING THE SURGERY THE PATIENT WAS FINE. THE AUS DEVICE HAS NOT BEEN ACTIVATED YET.

  Patient problems: Incontinence

  MAUDE report 10501778 ↗
• InjuryAug 18, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING RECURRENCE OF HIS INCONTINENCE AFTER BEING IMPLANTED WITH AN ADVANCE XP SLING DEVICE. FOLLOWING IMPLANTATION OF THE SLING THE PATIENT'S INCONTINENCE WAS BETTER THAN BASELINE DURING THE FIRST WEEK. THEN, STARTING ON (B)(6) 2019, THE PATIENT BEGAN EXPERIENCING INCREASING STRESS INCONTINENCE BACK TO THE SAME LEVEL AS PRIOR TO HAVING THE SLING DEVICE IMPLANTED. IT IS BELIEVED THAT THERE MAY HAVE BEEN A DISPLACEMENT OF THE SLING. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Incontinence

  MAUDE report 10419459 ↗