E-Luminexx® Vascular & Biliary Stent ZBM08040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519009377), received between Nov 11, 2015 and Aug 14, 2023 — classified as 4 malfunctions.

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

• MalfunctionAug 14, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY DEFECTIVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538423 ↗
• MalfunctionOct 31, 2019Premature Activation; Positioning Problem; Premature Activation; Positioning Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A FISTULA IN THE ARM, THE STENT ALLEGEDLY PREMATURELY DEPLOYED WITH THE SAFETY CLIP IN PLACE AFTER ADVANCING THROUGH THE INTRODUCER SHEATH AND WHILE ENTERING THE PATIENT ANATOMY. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED WITHOUT INCIDENT AND ANOTHER DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9264050 ↗
• MalfunctionMay 11, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF AN IN-STENT RESTENOSIS IN THE CEPHALIC ARCH VIA ACCESS THROUGH THE RIGHT LOWER ARM, THE STENT COULD NOT BE DEPLOYED. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559628 ↗
• MalfunctionNov 11, 2015Failure to Advance; Mechanical Jam

  IT WAS REPORTED THAT AFTER PREPARATION AND PRIOR TO PATIENT CONTACT, THE STENT DELIVERY SYSTEM GOT STUCK DURING THE ATTEMPT TO LOAD IT OVER A 0.035 INCH GUIDE WIRE. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5217195 ↗