LifeStar® Biliary Stent VIUS10120Recalls & reported problems
Bard Peripheral Vascular, Inc. · LifeStar® Biliary Stent 10 mm x 120 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049519005584), received between Mar 10, 2016 and May 28, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Misfire” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Misfire2
- Material Deformation1
- Positioning Failure1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2024Misfire; Material Deformation; Misfire; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA PROXIMAL BASILIC VEIN, THE STENT ALLEGEDLY DID NOT DEPLOY COMPLETELY. IT WAS FURTHER REPORTED THAT THE BACK END OF THE STENT ALLEGEDLY DID NOT COME OUT. REPORTEDLY, THE HEALTHCARE PROFESSIONAL TRIED TO PUSH FORWARD THE STENT OUT, BUT IT ENDED UP ELONGATING THE STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19403532 ↗MalfunctionNov 27, 2023Misfire; Misfire
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18212130 ↗MalfunctionMar 10, 2016Positioning Failure; Stretched
IT WAS REPORTED THAT THE BILIARY STENT WHICH WAS INTENDED TO BE PLACED AT THE APEX OF A FOREARM GRAFT, DID NOT DEPLOY SIMULTANEOUSLY RESULTING IN THE STENT TO BE ELONGATED. THE DELIVERY SYSTEM AND STENT GRAFT WERE REMOVED FROM THE PATIENT WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00073.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5492926 ↗
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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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