Percuflex™ Plus M006175263010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729302032), received between Nov 16, 2020 and Jul 16, 2024 — classified as 2 injuries, 4 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A URETEROSCOPY PROCEDURE, A PERCULFEX PLUS URETERAL STENT WAS GOING TO BE USED. DURING PREPARATION, THE PHYSICIAN FOUND THAT THE STENT WAS FRACTURED. ANOTHER OF THE SAME WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755454 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A UROLOGY STENT PROCEDURE IN THE KIDNEY ON AN UNSPECIFIED DATE. POST PROCEDURE, THE PATIENT EXPERIENCED BURNING URINATION AND A BLADDER INFECTION. AN EARLY, UNPLANNED STENT REMOVAL PROCEDURE WAS PERFORMED, ON (B)(6) 2023, TO EXPLANT THE STENT. ANOTHER DEVICE OF THE SAME MODEL WAS IMPLANTED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO MEDICATION OR TREATMENT GIVEN TO THE PATIENT FOR THE BURNING URINATION AND BLADDER INFECTION. THE PATIENT'S CONDITION WAS REPORTED AS STABLE, AND THE EVENT WAS NOTED TO HAVE BEEN RESOLVED APPROXIMATELY ONE MONTH AFTER STENT REMOVAL.

  Patient problems: Burning Sensation; Urinary Tract Infection

  MAUDE report 16724650 ↗
• MalfunctionMar 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A UROLOGY STENTING PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTED THAT THE STENT BECAME BROKEN WHEN THE SUTURE WAS REMOVED. IT WAS REPORTED THAT THE STENT SHAFT WAS BROKEN INTO TWO PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PERCUFLEX PLUS URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535607 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A UROLOGY STENTING PROCEDURE IN THE URETER PERFORMED ON (B)(6), 2023. AFTER THE STENT IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND A BLADDER INFECTION. THE STENT REMAINED IMPLANTED FOR "ABOUT" ONE WEEK, BUT THEN THE PHYSICIAN HAD TO REMOVE IT PRIOR TO THE PLANNED REMOVAL. IT WAS NOTED THAT THERE WAS NO DEVICE MALFUNCTION, AND NO PRESCRIBED MEDICINE WAS GIVEN TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 16399053 ↗
• MalfunctionJan 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A STENT REPLACEMENT PROCEDURE IN THE URETER, PERFORMED ON "(B)(6) 2021". DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN DEPLOYED THE STENT AND REMOVED THE GUIDEWIRE, IT WAS NOTICED THAT A PIECE OF THE STENT BROKE. NO OTHER DEVICE WAS USED TO GRASP THE BROKEN PIECE OF STENT. ANOTHER PERCUFLEX PLUS WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT A PIECE OF THE STENT COIL WAS DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196991 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URETERAL STENT WAS OPEN TO BE USED DURING A FLEXIBLE URETEROSCOPY WITH LASER PROCEDURE IN THE URETER FOR BILATERAL NEPHROLITHIASIS, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN REMOVED THE STENT FROM THE PACKAGING, IT WAS NOTICED THAT THE STENT SHAFT WAS BROKEN IN THE MIDDLE. ANOTHER PERCUFLEX URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10844345 ↗