Percuflex Urinary Diversion StentRecalls & reported problems across all models

We found 3 models of Percuflex Urinary Diversion Stent by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2017 and Jun 23, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Percuflex Urinary Diversion Stent problems

Percuflex Urinary Diversion Stent models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Percuflex™ Urinary Diversion Stent M0061603300

  CATHETER, NEPHROSTOMY
  10 reports
• Percuflex™ Urinary Diversion Stent M0061603250

  CATHETER, NEPHROSTOMY
  9 reports
• Percuflex™ Urinary Diversion Stent M0061603350

  CATHETER, NEPHROSTOMY
  4 reports

Recent Percuflex Urinary Diversion Stent adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Break; Nonstandard Device; Material Deformation

  IT WAS REPORTED THAT A URINARY DIVERSION STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PIGTAIL PART WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT SHAFT BREAK. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591900 ↗
• 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 ↗
• InjuryMay 15, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE WAS UNABLE TO CROSS. THE GUIDEWIRE COULD NOT BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032475 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 21, 2023Material 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 PERFORMED ON SEPTEMBER 25, 2023. DURING THE PROCEDURE, THE STENT WAS DAMAGED. IT WAS NOTED THAT THE PIGTAIL PART WAS TORN. 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 18379515 ↗
• 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 ↗

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