Percuflex™ Urinary Diversion Stent Set M0061602100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729297178), received between Dec 19, 2016 and Jul 22, 2025 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A URINARY DIVERSION STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE PRODUCT PACKAGING WAS TORN. IT WAS ALSO REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22570878 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT ARRIVED FOR A STENT EXCHANGE, WHILE THE WIRE WAS TRYING TO ADVANCE THE STENT, IT WAS NOTICED THAT THERE WAS SOME RESISTANCE. ON THE X-RAY IT WAS NOTICED THAT THE STENT HAD BROKEN IN MULTIPLE PLACES.

  Patient problems: Foreign Body In Patient

  MAUDE report 22330360 ↗
• InjuryJun 23, 2025Break; Break

  IT WAS REPORTED THAT A PERCUFLEX URINARY DIVERSION STENT WAS IMPLANTED INTO THE PATIENT DURING A STENT EXCHANGE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM FOR SEPSIS. IMAGING REVEALED FRAGMENTATION OF THE URETERAL STENT, WITH RETAINED FRAGMENTS IN THE URETER. THE PATIENT HAD A NEPHROSTOMY TUBE FOR DRAINAGE AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). SURGICAL INTERVENTION WAS PLANNED FOR THE REMOVAL OF THE RETAINED STENT FRAGMENTS. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Sepsis

  MAUDE report 22311653 ↗
• DeathJun 12, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE FRACTURED SINGLE J STENT WAS UNABLE TO BE REMOVED AT THE TIME OF STENT CHANGE RESULTING IN RETAINED FRAGMENT WITH SUBSEQUENT SEPSIS, AND DEATH.

  Patient problems: Foreign Body In Patient; Sepsis

  MAUDE report 22198928 ↗
• MalfunctionDec 18, 2023Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT MFR. REPORT # 2124215-2023-70020). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION STENT SET WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE TO TREAT KIDNEY STONES IN THE URETHRA, BLADDER AND URETER. THE EXACT EVENT DATE WAS NOT REPORTED. DURING THE PROCEDURE, WHEN THE DEVICE WAS INSERTED, THE STENT WAS FOUND BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 18343857 ↗
• MalfunctionOct 30, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION STENT SET WAS USED DURING A CATHETER REPLACEMENT PROCEDURE. THE EXACT EVENT DATE WAS NOT REPORTED. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, A KINK WAS DISCOVERED. IT WAS ALSO NOTED THAT THE STENT SHAFT WAS BROKEN IN HALF. THE PROCEDURE WAS COMPLETED USING ANOTHER PERCUFLEX URINARY DIVERSION STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031167 ↗
• InjuryDec 19, 2016Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PERCUFLEX¿ URINARY DIVERSION STENTS WERE IMPLANTED DURING A CYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2016 AND WERE REMOVED DURING A STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2016 AND ANOTHER ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, A CYSTECTOMY PROCEDURE WAS PERFORMED AND TWO DIVERSION STENTS WERE IMPLANTED, ONE IN EACH URETER. THE STENTS WERE WITHDRAWN DURING A SCHEDULED STENT REMOVAL ON (B)(6) 2016 . THE STENT IN THE LEFT URETER WAS REMOVED WITHOUT ANY PROBLEMS. HOWEVER, THE STENT AT THE RIGHT URETER ¿SNAPPED¿ WHILE BEING PULLED OUT, LEAVING A DETACHED PIECE LEFT INSIDE THE PATIENT. ON (B)(6) 2016, AN ATTEMPT TO REMOVE THE DETACHED PIECE WAS MADE, BUT WAS UNSUCCESSFUL. ON (B)(6) 2016, A BIGGER NEPHROSTOMY BALLOON WAS PLACED. ON (B)(6) 2016, AN ANTEGRADE AND RETROGRADE URETEROSCOPY PROCEDURE WAS PERFORMED AND SUCCESSFULLY RETRIEVED THE REMAINING PART OF THE STENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6184795 ↗