Percuflex™ Urinary Diversion Stent M0061603300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729821144), received between Apr 5, 2017 and Apr 17, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE INSIDE OF THE PIGTAIL SECTION WAS KINKED AND THE GUIDE WIRE COULD NOT PASS THROUGH. THE DEVICE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860653 ↗
• MalfunctionFeb 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING THE TRANSURETHRAL URETERAL STENT PLACEMENT PROCEDURE USING THE PERCUFLEX URINARY DIVERSION STENT, THE STENT WAS FOUND KINKED. ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE RETUNED DEVICE IDENTIFIED THAT THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454738 ↗
• MalfunctionDec 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING THE PROCEDURE A PERCUFLEX URINARY DIVERSION URETERAL STENT WAS USED, AND THE STENT WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930397 ↗
• MalfunctionMar 28, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE STENT WAS DAMAGED. IT WAS FOUND THAT THE PIGTAIL PART WAS KINKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PERCUFLEX URINARY DIVERSION STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000475 ↗
• MalfunctionJan 10, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE STENT WAS FOUND DAMAGED. IT WAS NOTED THAT THE STENT WAS KINKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PERCUFLEX URINARY DIVERSION STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489189 ↗
• MalfunctionMay 23, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN PERCUFLEX URINARY DIVERSION STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS FOUND THAT THE GUIDEWIRE COULD NOT CROSS AND THE TIP OF THE PERCUFLEX URINARY DIVERSION STENT WAS FLATTENED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PERCUFLEX URINARY DIVERSION 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 AS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14477362 ↗
• MalfunctionMar 31, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION URETERAL STENT WAS USED DURING A URETERAL STENTING PROCEDURE IN THE RENAL PELVIS AND URETER. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, IT WAS NOTICED THAT THE RENAL SIDE PIGTAIL WAS KINKED. ANOTHER URINARY DIVERSION STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT SHAFT BROKEN. PLEASE SEE BLOCK FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967041 ↗
• MalfunctionOct 1, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN URINARY DIVERSION STENT WAS USED IN A PROCEDURE. THE EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS KINKED AT THE DISTAL TIP. ANOTHER URINARY DIVERSION STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE STENT SHAFT WAS DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9140543 ↗
• InjuryNov 5, 2018Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX STENT WAS IMPLANTED IN A PATIENT ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT CAME BACK TO THE HOSPITAL FOR REASONS UNKNOWN AND IT WAS DISCOVERED THAT THE STENT HAD MIGRATED. IT WAS REPORTED THAT THE STENT MAY HAVE MIGRATED DUE TO THE STENT LENGTH BEING INCORRECT. A SECOND PERCUFLEX STENT WAS THEN IMPLANTED IN THE PATIENT. THERE WAS NO SERIOUS INJURY NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO IN STABLE CONDITION POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039410 ↗
• MalfunctionApr 5, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ URINARY DIVERSION STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE STENT WAS FOUND KINKED. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT SHAFT WAS FOUND BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461786 ↗