LifeStar® Vascular & Biliary Stent VIUS08080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519005423), received between Dec 9, 2015 and Dec 9, 2015 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

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.

• MalfunctionDec 9, 2015Patient-Device Incompatibility; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE STENT WAS FOUND TO HAVE A DIFFERENT LENGTH THAN INTENDED AFTER IMPLANTATION. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 5276743 ↗
• MalfunctionDec 9, 2015Labelling, Instructions for Use or Training Problem; Inadequacy of Device Shape and/or Size; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE STENT WAS FOUND TO BE LONGER THAN INTENDED POST IMPLANTATION UNDER FLUOROSCOPY (100 MM INSTEAD OF 80 MM LENGTH). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5276609 ↗