Percuflex™ Nephroureteral Stent M001231420Recalls & reported problems
Boston Scientific Corporation · Nephroureteral Stent System with Dissolving Tip · 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 08714729031703), received between Mar 3, 2022 and Oct 21, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Deformation1
- Material Twisted/Bent1
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.
MalfunctionOct 21, 2024Material Deformation; Material Deformation
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-SEP 2024. IT WAS REPORTED THAT THE NEPHROURETERAL TUBE WAS CRIMPED. AN IE TEMP TIP 10/26 OTHER URINARY WAS SELECTED FOR A NEPHROURETERAL TUBE PLACEMENT. WHEN THE PACKAGE HAD BEEN OPENED, IT WAS DISCOVERED THAT THE TUBE WAS CRIMPED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE STENT WAS CRUSHED AND TORN, AND THE SUTURE WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20495477 ↗MalfunctionMar 3, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS NOTED THAT THE DEVICE TIP BROKE OFF. A 10/26 PERCUFLEX NEPHROURETERAL STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TEMP TIP BUCKLED UPON ENTRY. SUBSEQUENTLY, THE TIP BROKE OFF IN THE SUBCUTANEOUS TISSUE. THE DETACHED TIP WAS RETRIEVED 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 13664848 ↗
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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