E-Luminexx® Vascular & Biliary Stent ZBM10080Recalls & reported problems
Bard Peripheral Vascular, Inc. · Bard® E-LUMINEXX™ Vascular and Biliary Stent 10 mm x 80 mm (80 cm delivery catheter) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519009513), received between Nov 22, 2024 and Aug 26, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
- Difficult or Delayed Positioning1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2025Break; Difficult or Delayed Positioning; Detachment of Device or Device Component; Break; Difficult or Delayed Positioning; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT STENT PLACEMENT USING THE E-LUMINEXX BILIARY STENT. DURING THE PROCEDURE, THE STENT FAILED TO RELEASE, AND THE DEPLOYMENT DEVICE BROKE, LEAVING A FRAGMENT INSIDE THE PATIENT. HOWEVER, THE CURRENT PATIENT STATUS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 22892083 ↗InjuryNov 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE MARKER OF THE STENT ALLEGEDLY BROKE WITHIN INSIDE THE PATIENT. THE CURRENT STATUS OF PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 20756512 ↗
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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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