E-Luminexx® Vascular & Biliary Stent ZBM07040Recalls & reported problems
Bard Peripheral Vascular, Inc. · Bard® E-LUMINEXX™ Vascular and Biliary Stent 7 mm x 40 mm (80 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049519009315), received between Jul 12, 2018 and Jul 12, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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
- Unsealed Device Packaging1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2018Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT UPON OPENING OF THE DEVICE PACKAGING, THE STERILE BARRIER ALLEGEDLY WAS NOT COMPLETELY SEALED. REPORTEDLY, ANOTHER VASCULAR STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7683655 ↗
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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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