Percuflex™ Urinary Diversion Stent M0061603350Recalls & reported problems
Boston Scientific Corporation · Urinary Diversion Stent · Class U · Implant
All models of Percuflex Urinary Diversion Stent (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729821151), received between Jan 18, 2022 and Jun 23, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Difficult to Advance1
- Material Split, Cut or Torn1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, 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 ↗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 ↗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 ↗MalfunctionJan 18, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A PERCUFLEX URINARY DIVERSION STENT WAS USED DURING A STENT IMPLANTATION PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. DURING PROCEDURE, IT WAS FOUND THAT ONE OF THE PIGTAIL COILS WAS SLIGHTLY BENT AND COULD NOT BE IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 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. PLEASE NOTE, THIS HAS BECOME REPORTABLE BASED ON INVESTIGATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13286301 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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