Percuflex™ Urinary Diversion Stent M0061603250Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729821137), received between May 4, 2017 and Feb 11, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PERCUFLEX URINARY DIVERSION STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, A SMALL DEBRIS-LIKE PIECE WAS FOUND INSIDE THE PACKAGING. 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 24315250 ↗
• MalfunctionApr 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING THE PROCEDURE, A HAIR-LIKE SUBSTANCE WAS FOUND IN THE UNOPENED PACKAGE. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860426 ↗
• MalfunctionApr 5, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (SEE MFR REPORT # 2124215-2024-17751.). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION STENT WAS SUCCESSFULLY IMPLANTED DURING A PROCEDURE. THE EVENT DATE WAS NOT REPORTED. DURING A ROUTINE FOLLOW-UP, THE TWO IMPLANTED STENTS FROM LEFT AND RIGHT ANATOMY WERE FOUND TORN AT THE PART PROTRUDING OUTSIDE THE PATIENT. 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 19055708 ↗
• MalfunctionMar 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION STENT WAS USED DURING A PROCEDURE. THE EVENT DATE WAS NOT REPORTED. DURING THE PROCEDURE, THE STENT WAS FOUND DAMAGED. 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 19000908 ↗
• MalfunctionMar 28, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # MFR. REPORT # 2124215-2024-17757). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION STENT WAS SUCCESSFULLY IMPLANTED DURING A PROCEDURE. THE EVENT DATE WAS NOT REPORTED. DURING A ROUTINE FOLLOW-UP, THE TWO IMPLANTED STENTS FROM LEFT AND RIGHT ANATOMY WERE FOUND TORN AT THE PART PROTRUDING OUTSIDE THE PATIENT. 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 19000726 ↗
• MalfunctionAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION STENT WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WITHDRAWAL/CLOSURE OF THE PROCEDURE, THE STENT WAS BROKEN ABOUT 15 CM FROM THE PIGTAIL. REPORTEDLY, THE BROKEN STENT WAS REMOVED AND THERE WERE NO FRAGMENTS OF THE PERCUFLEX URINARY DIVERSION STENT LEFT INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10367636 ↗
• MalfunctionMar 16, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION URETERAL STENT WAS USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE GOT STUCK AT THE TIP SIDE OF THE CATHETER AND WAS UNABLE TO CROSS. ANOTHER PERCUFLEX URINARY DIVERSION URETERAL 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 RESULTS; STENT SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9837304 ↗
• InjuryApr 11, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URINARY DIVERSION STENT WAS IMPLANTED IN THE KIDNEY AND BLADDER FOR A TOTAL CYSTECTOMY PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, ONE WEEK AFTER THE OPERATION ON (B)(6), 2019, DURING WITHDRAWAL, THE STENT WAS REMOVED. IT WAS REPORTED THAT THE STENT WAS INDWELLED IN A SITUATION WHERE THERE WAS A LOOP IN THE NEW BLADDER. THE STENT WAS NOTICED TO BE DETACHED IN THE BLADDER SIDE. THE DETACHED STENT WAS COMPLETELY REMOVED THROUGH THE USE OF A CYSTOSCOPE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505867 ↗
• MalfunctionMay 4, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ URINARY DIVERSION STENT WAS SUPPOSED TO BE USED FOR A PROCEDURE (EXACT DATE NOT REPORTED). ACCORDING TO THE COMPLAINANT, DURING UNPACKING "IT WAS FOUND THAT THE DEVICE WAS NOT SEALED IN A STERILE BAG¿. REPORTEDLY, THE DEVICE WAS NOT RECEIVED IN A STERILE DEVICE POUCH. THE DEVICE WAS NOT USED IN THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX¿ URINARY DIVERSION STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN DETAILS REGARDING THE EVENT DESCRIPTION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6546627 ↗