LifeStar® Biliary Stent VIUS14040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519005683), received between Jan 1, 2016 and Oct 24, 2019 — classified as 1 injury, 1 malfunction.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2019Entrapment of Device; Fracture; Difficult to Remove; Entrapment of Device; Fracture; Difficult to Remove

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUBCLAVIAN VEIN, AFTER STENT PLACEMENT THE STENT GOT CAUGHT ON THE PTA BALLOON, CAUSING THE STENT TO ALLEGEDLY FRACTURE. IT WAS FURTHER REPORTED THAT A NEW DELIVERY SYSTEM WAS USED TO PLACE A NEW STENT INSIDE THE ORIGINAL FRACTURED AND FOLDED STENT. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9235402 ↗
• MalfunctionJan 1, 2016Break; Failure to Advance; Break; Premature Activation; Material Separation; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE STENT SYSTEM WOULD NOT TRACK OVER THE 0.035 '' ACCESS WIRE SMOOTHLY AND THAT PRIOR TO THE STENT SYSTEM ENTERING THE PATIENT, THE STENT ALLEGEDLY BEGAN TO DEPLOY. IT WAS FURTHER REPORTED THAT AS THE HCP WAS REMOVING THE STENT SYSTEM, THE INNER LINING OF THE DEVICE SEPARATED FROM THE DEVICE AND STAYED ON THE WIRE. ANOTHER STENT WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 5339661 ↗