LifeStar® Biliary Stent VIUS12080Recalls & reported problems
Bard Peripheral Vascular, Inc. · LifeStar® Biliary Stent 12 mm x 80 mm (80 cm delivery catheter) · Class 2 · Implant
All models of LifeStar Biliary Stent (10)
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 04049519005638), received between Mar 8, 2017 and Mar 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
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.
MalfunctionMar 8, 2017Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE BILIARY STENT COULD NOT BE DEPLOYED. ANOTHER STENT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6387678 ↗
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- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
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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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