LifeStar® Vascular & Biliary Stent VIUS07040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519005331), received between Dec 22, 2015 and May 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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.

• MalfunctionMay 17, 2018Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A BILIARY STENT DEPLOYMENT PROCEDURE, THE STENT DEPLOYED BUT ALLEGEDLY WOULD NOT EXPAND. REPORTEDLY, ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7522920 ↗
• MalfunctionDec 22, 2015Break; Detachment Of Device Component; Difficult to Remove; Sticking

  IT WAS REPORTED THAT POST DEPLOYMENT OF THE STENT IN THE EXTERNAL ILIAC CREST, DURING RETRACTION THE DELIVERY SYSTEM BECAME STUCK AND THE CATHETER DETACHED FROM THE DEVICE. THERE WERE SOME DIFFICULTIES IN RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 5320820 ↗