E·Luminexx® Biliary Stent ZBM12040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04049519010366), received between Feb 7, 2017 and Mar 9, 2026 — classified as 1 death, 4 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Difficult or Delayed Positioning; Malposition of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING AN E-LUMINEXX VASCULAR STENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY BECAME JAMMED IN THE DELIVERY SYSTEM AND SUBSEQUENTLY JUMPED OUT, MISSING THE INTENDED TARGET LOCATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543274 ↗
• MalfunctionJan 5, 2021Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THAT POST STENT PLACEMENT, THE TANTALUM MARKER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11116231 ↗
• MalfunctionNov 30, 2017Failure to Advance; Device Contamination with Chemical or Other Material; Failure to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING DEPLOYMENT PROCEDURE A BILIARY STENT ALLEGEDLY COULD NOT BE ADVANCED BECAUSE A PIECE OF MELTED GLUE OR PLASTIC WAS ALLEGEDLY FOUND ATTACHED TO THE OUTER SURFACE. REPORTEDLY, THE DEVICE WAS REMOVED WITHOUT ANY ISSUES AND ANOTHER STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7072854 ↗
• DeathOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE IN THE INFRA-RENAL ABDOMINAL ARTERY AN AORTIC LEAK DEVELOPED, AND DESPITE RESUSCITATION ATTEMPTS, THE PATIENT EXPIRED AFTER BEING TRANSFERRED TO ANOTHER FACILITY FOR VASCULAR INTERVENTION.

  Patient problems: Death

  MAUDE report 6970631 ↗
• MalfunctionFeb 7, 2017Break; Positioning Failure; Detachment of Device or Device Component; Break; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WHITE END PIECE OF THE DELIVERY SYSTEM ALLEGEDLY BROKE BEFORE THE STENT WAS DEPLOYED IN THE LEFT BRACHIOCEPHALIC VEIN VIA ACCESS THROUGH THE LEFT ARM. REPORTEDLY, THE VESSEL HAD BEEN PRE-DILATED AND THE USER HAD DIFFICULTIES IN ADVANCING THE DELIVERY SYSTEM TO THE LESION SITE. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6307042 ↗