LifeStar® Vascular & Biliary Stent VIUS07060Recalls & reported problems
Bard Peripheral Vascular, Inc. · LifeStar™ Vascular and Biliary Stent System 7 mm x 60 mm (80 cm delivery catheter) · Class 2 · Implant
All models of LifeStar Vascular & Biliary Stent (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519005348), received between Dec 2, 2015 and Jul 17, 2023 — classified as 2 malfunctions.
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
- Detachment of Device or Device Component1
- Difficult to Remove1
- Failure to Advance1
- Material Deformation1
- Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY WOULDN'T CROSS OVER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17332128 ↗MalfunctionDec 2, 2015Break; Difficult to Remove; Sticking; Detachment of Device or Device Component
IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT OF THE STENT, A PART OF THE INNER CATHETER OF THE DELIVERY SYSTEM WAS FOUND TO HAVE DETACHED AND STICKING ON THE GUIDE WIRE. SOME RESISTANCE WAS FELT DURING RETRACTION OF THE DELIVERY SYSTEM FROM THE GUIDE WIRE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 5260072 ↗
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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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