LifeStar® Vascular & Biliary Stent VIUS10040Recalls & reported problems
Bard Peripheral Vascular, Inc. · LifeStar™ Vascular and Biliary Stent System 10 mm x 40 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049519005546), received between Oct 24, 2016 and Oct 24, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
- Migration or Expulsion of Device1
Patient problems
- No Consequences Or Impact To Patient1
- Vascular System (Circulation), Impaired1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2016Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device
IT WAS REPORTED THAT THE STENT WAS DEPLOYED IN THE ILIAC VEIN AND ALLEGEDLY MOVED TO AN UNINTENDED LOCATION IN THE VENA CAVA RESULTING IN THE DEPLOYMENT OF AN ADDITIONAL STENT TO BRIDGE BOTH STENTS. REPORTEDLY, THE STENT WAS INTENDED TO BE PLACED IN THE ILIAC VEIN IN A LEG GRAFT. THE STENT REMAINS IMPLANTED AND THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient; Vascular System (Circulation), Impaired
MAUDE report 6050148 ↗
Other CATHETER, BILIARY, DIAGNOSTIC devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page