Percuflex™ Nephroureteral Stent M001221370Recalls & reported problems
Boston Scientific Corporation · Nephroureteral Stent System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729114086), received between May 16, 2023 and Aug 22, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Break; Break
IT WAS REPORTED THAT CATHETER BREAK OCCURRED. A PERCUFLEX NEPHROURETERAL STENT WAS SELECTED FOR USE FOR A LEFT ANTEGRADE URETERIC STENTING. DURING THE PROCEDURE, A GUIDEWIRE WAS INSERTED AND PLACED INTO THE URINARY SYSTEM. CONSEQUENTLY, A PERCUFLEX WAS ADVANCED. HOWEVER, WHEN STRING WAS PULLED, THE CATHETER SPLIT INTO TWO. THE DEVICE WAS FULLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20044181 ↗MalfunctionMay 16, 2023Break; Break
IT WAS REPORTED THAT THE STENT DETACHMENT OCCURRED. A PERCUFLEX NEPHROURETERAL STENT WAS SELECTED FOR USE IN THE URINARY BLADDER. DURING THE PROCEDURE, THE NEPHROURETERAL STENT WAS ADVANCED OVER THE GUIDEWIRE INTO THE URINARY BLADDER. THE GUIDEWIRE WAS REMOVED TO FORM THE NEPHROURETERAL STENT. THE SUTURE WAS PULLED TO CREATE THE PIGTAIL AND UPON REMOVING OVER THE WIRE, IT WAS NOTED THAT A FRACTURE OCCURRED AT THE PROXIMAL END OF THE CATHETER DISTAL TO THE HUB AND AT THE DISTAL THIRD. THE GUIDE WIRE WAS READVANCED TO REMOVE THE NEPHROURETERAL STENT AND RESISTANCE WAS MET. THE NEPHROURETERAL STENT WAS REMOVED OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16938428 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
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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