Expel™ Nephroureteral Stent System with Twist-Loc™ Hub H7493935108260Recalls & reported problems
Boston Scientific Corporation · Nephroureteral Stent System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729860945), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
- Entrapment of Device1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2020Break; Entrapment of Device; Break; Entrapment of Device
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27OCT2020. IT WAS REPORTED THAT THE FLEXIBLE CANNULA BECAME STUCK AND BROKE INSIDE THE CATHETER. AN 8.3/26 EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PLASTIC STYLET WOULD GET STUCK IN THE DRAINAGE CATHETER WITH THE WIRE IN PLACE. THEN, IT WAS NOTED THAT THE SOFT PLASTIC STIFFENER BROKE OFF IN THE DRAINAGE CATHETER. THE PHYSICIAN HAD TO REMOVE EVERYTHING FROM THE PATIENT AND START OVER. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT MIDDLE SECTION WAS DETACHED/SEPARATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10791796 ↗
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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