Expel™ Nephroureteral Stent System with Twist-Loc™ Hub H7493935108280Recalls & 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 08714729860952), received between Dec 9, 2019 and Dec 9, 2019 — 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
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.
MalfunctionDec 9, 2019Break; Break
IT WAS REPORTED THAT THE TIP OF THE STENT BROKE OFF. AN 8.3/28 EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB WAS SELECTED FOR USE. DURING PROCEDURE, THE DEVICE WAS PLACED ONTO THE WIRE AND TRIED TO PASS THROUGH THE SKIN. HOWEVER, THE TIP OF THE STENT BROKE OFF CAUSING A LOSS OF ACCESS AND WIRE POSITION. EVERYTHING WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME SIZE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED, THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT KIDNEY ARTERY. ALSO, THE DEVICE WAS JUST REMOVED FROM THE PATIENT'S BODY WITHOUT ANY FRAGMENTS LESFT INSIDE THE PATIENT. THE PATIENT'S CONDITION POST PROCEDURE IS SATISFACTORY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9439710 ↗
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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