E·Luminexx® Biliary Stent ZBL14060Recalls & reported problems
Bard Peripheral Vascular, Inc. · E·Luminexx® Biliary Stent 14 mm x 60 mm (135 cm delivery catheter) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049519010199), received between Sep 16, 2019 and Sep 16, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
Device problems
- Fracture1
- Premature Activation1
- Retraction Problem1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2019Fracture; Premature Activation; Retraction Problem; Fracture; Premature Activation; Retraction Problem
IT WAS REPORTED THAT DURING TREATMENT OF THE RIGHT BRACHIOCEPHALIC VEIN INTO THE SUPERIOR VENA CAVA, THE BILIARY STENT ALLEGEDLY PREMATURELY DEPLOYED AS IT WAS BEING ADVANCED THROUGH THE INTRODUCER SHEATH. THEREFORE, THE DELIVERY SYSTEM WAS RETRACTED FROM THE INTRODUCER SHEATH CAUSING THE STENT TO FRACTURE AND REQUIRING THE STENT TO BE REMOVED IN PIECES. REPORTEDLY, A PTA BALLOON CATHETER WAS USED TO PERFORM ANGIOPLASTY AND COMPLETE THE PROCEDURE. HOWEVER, APPROXIMATELY A WEEK LATER THE PATIENT REQUIRED AN ADDITIONAL STENT. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Injury
MAUDE report 9072995 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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