LifeStar® Biliary Stent VIUS12040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519005614), received between Mar 8, 2016 and Sep 2, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTAR. DURING THE PROCEDURE THE DEVICE COULDN¿T ADVANCE THROUGH THE COOK SHEATH. THE GUIDEWIRE KINKED, RESULTING IN LOSS OF ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929944 ↗
• MalfunctionJun 9, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE STENT ALLEGEDLY BROKE RESPECTIVELY FRACTURED DURING STENT DEPLOYMENT PROCEDURE IN CEPHALIC VEIN. THERE WAS NO REPORTED INTERVENTION REQUIRED AND THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11965114 ↗
• InjuryMay 18, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT APPROXIMATELY THREE YEAR AFTER STENT PLACEMENT IN THE RENAL VEINS, THE STENT ALLEGEDLY KINKED AND PROTRUDED THROUGH THE VEIN WALL. IT WAS FURTHER REPORTED THAT THE STENT HAD TO BE REMOVED ALONG WITH SECTIONS OF THE RENAL VEIN DUE TO THE DAMAGE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 10068077 ↗
• MalfunctionMar 8, 2016Premature Activation; Premature Activation; Malposition of Device

  IT WAS REPORTED THAT AFTER INSERTION OF THE DELIVERY SYSTEM BUT PRIOR TO STENT DEPLOYMENT IN THE ILIAC ARTERY, THREE RADIOPAQUE MARKERS WERE OBSERVED IN THE DISTAL SECTION OF THE DELIVERY SYSTEM UNDER FLUOROSCOPY. IT WAS IDENTIFIED THAT THE DISTAL STENT MARKER SPOONS WHICH WERE SUPPOSED TO BE IN LINE WITH THE CATHETER MARKER BAND WERE LOCATED DISTAL TO THE MARKER BAND OF THE CATHETER. REPORTEDLY, THE SAFETY CLIP WAS IN PLACE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5486206 ↗