LifeStar® Biliary Stent VIUS12120Recalls & reported problems
Bard Peripheral Vascular, Inc. · LifeStar® Biliary Stent 12 mm x 120 mm (80 cm delivery catheter) · Class 2 · Implant
All models of LifeStar Biliary Stent (10)
Data updated Oct 16, 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 04049519005652), received between Oct 27, 2016 and Oct 27, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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 16, 2026.
Most reported problems
Device problems
- Premature Activation1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2016Premature Activation; Premature Activation
IT WAS REPORTED THAT DURING PREPARATION OF THE DELIVERY SYSTEM, THE BILIARY STENT WAS FOUND TO BE PARTIALLY DEPLOYED. REPORTEDLY, THE SAFETY CLIP WAS REMOVED BY THE CUSTOMER. ANOTHER STENT WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED PATIENT INJURY.
Patient problems: No Patient Involvement
MAUDE report 6059803 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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