E·Luminexx® Biliary Stent ZBM14040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519010434), received between Jan 25, 2021 and Oct 25, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 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.

• InjuryOct 25, 2024Break; Detachment of Device or Device Component; Migration; Break; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT RENAL VEIN, THE STENT ALLEGEDLY EMBOLIZED TO INTRAVASCULAR ULTRASOUND. IT WAS FURTHER REPORTED THAT THE HALF OF STENT WAS SNARED WITH A LARGE SHEATH AND REST OF THE STENT WAS EXPLANTED WHICH LEFT IN THE ILIAC AND THE GROIN WAS CLOSED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Embolism/Embolus

  MAUDE report 20531252 ↗
• MalfunctionAug 28, 2023Premature Activation; Misfire; Premature Activation; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC LESION VIA LEFT COMMON FEMORAL ACCESS, THE STENT WAS ALLEGEDLY PARTIALLY DEPLOYED DESPITE STILL HAVING THE SAFETY ON. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17629461 ↗
• MalfunctionNov 1, 2021Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT SUBCLAVIAN VEIN, THE STENT ALLEGEDLY PREMATURELY DEPLOYED. IT WAS FURTHER REPORTED THAT THE CENTER OF THE STENT ALLEGEDLY ELONGATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726030 ↗
• InjuryJan 25, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DEPLOYED PREMATURELY. ADDITIONAL INTERVENTION WAS REQUIRED TO RECOVER THE STENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11222467 ↗