E·Luminexx® Biliary Stent ZBM12060Recalls & reported problems
Bard Peripheral Vascular, Inc. · E·Luminexx® Biliary Stent 12 mm x 60 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 04049519010373), received between Dec 22, 2017 and Dec 22, 2017 — classified as 1 malfunction.
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
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2017Fracture; Fracture
IT WAS REPORTED THAT DURING VASCULAR STENT ANGIOPLASTY PROCEDURE OF A HIGHLY STENOSED SUBCLAVIAN VEIN VIA A/V FISTULA, ANGIOPLASTY WAS PERFORMED PRE-AND POST-STENT DEPLOYMENT AND GUIDED FLUOROSCOPY ALLEGEDLY DEMONSTRATED A STENT FRACTURE POST DEPLOYMENT. ANGIOPLASTY WAS PERFORMED TO ADDRESS THE REMAINING STENOSIS WITHIN THE VESSEL AND COMPRESS THE FRACTURED STENT AGAINST THE VESSEL WALL. CONTRAST INJECTION DEMONSTRATED THE VESSEL WAS PATENT WITH GOOD BLOOD FLOW. THE HEALTH CARE PROVIDER STATED THAT NO ADDITIONAL TREATMENT WOULD BE PERFORMED AT THIS TIME. THERE IS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7144367 ↗
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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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