Percuflex™ M0061453510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729040262), received between Feb 2, 2021 and Feb 4, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Positioning Failure; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED DURING A LEFT URETERAL LITHOTRIPSY PROCEDURE, AND, DURING IMPLANTING THE STENT, RESISTANCE WAS FELT AT THE FRONT END AND COULD NOT BE IMPLANTED SMOOTHLY, RESULTING TO FOLDS AT THE FRONT AND BACK END OF THE DEVICE. 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 21308349 ↗
• MalfunctionSep 27, 2024Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LOWER PIGTAIL BAND WAS FOUND FRACTURED WHEN THE STENT TRIED TO BE PLACED. IT WAS NOTED THAT THE STENT WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20326783 ↗
• MalfunctionSep 23, 2024Entrapment of Device; Deformation Due to Compressive Stress; Material Deformation; Entrapment of Device; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT BEGAN TO BEND AND ACCORDION OVER THE WIRE. IT WAS NOTED THAT THE STENT GOT STUCK OVER THE WIRE CAUSING THE SURGEON TO REMOVE EVERYTHING FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20286098 ↗
• MalfunctionFeb 2, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URETERAL STENT WAS USED DURING A TRANSURETHRAL NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN FOUND THE STENT WAS BROKEN ALONG THE SHAFT AND THE PIGTAIL COIL WAS DETACHED. THE PROCEDURE WAS 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267320 ↗