Percuflex™ M0061453610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729040323), received between Jul 12, 2018 and Jun 20, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A PERCUFLEX URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2023. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN IN HALF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PERCUFLEX URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167064 ↗
• MalfunctionMar 11, 2022Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URETERAL STENT WAS USED DURING A STENT INSERTION IN THE URETER. DURING PROCEDURE, WHEN INSERTION WAS PERFORMED ON AN UNKNOWN DATE. IT WAS NOTED THAT THE PERCUFLEX URETERAL STENT ACCORDION UNDER THE LEAST AMOUNT OF PRESSURE FROM THE PUSHER AND WAS STUCK IN THE GUIDEWIRE WHEN PLACEMENT WAS PERFORMED. IT WAS REPORTED THAT THE PERCUFLEX URETERAL STENT KEEPS SHREDDING ONCE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13736528 ↗
• MalfunctionJul 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ STENT WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS PUT INSIDE THE PATIENT, AND IT WAS NOTICED THAT THE END PART OF THE STENT WAS MISSING. THE END PART WAS FOUND TO BE ON THE BACK TABLE. 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 Information

  MAUDE report 7681899 ↗