LifeStar® Biliary Stent VIUL14040Recalls & reported problems
Bard Peripheral Vascular, Inc. · LifeStar® Biliary Stent 14 mm x 40 mm (135 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 04049519005195), received between Aug 30, 2017 and Aug 30, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
- Premature Activation1
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.
MalfunctionAug 30, 2017Premature Activation; Failure to Advance; Premature Activation; Failure to Advance
IT WAS REPORTED THAT DURING AN ATTEMPT TO ADVANCE THE DELIVERY SYSTEM OVER THE GUIDEWIRE, THE VASCULAR STENT ALLEGEDLY STARTED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM ALLEGEDLY BECAME STUCK ON THE GUIDEWIRE; THEREFORE, EVERYTHING HAD TO BE REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6832824 ↗
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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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