E-Luminexx® Vascular & Biliary Stent ZBM08060Recalls & reported problems
Bard Peripheral Vascular, Inc. · Bard® E-LUMINEXX™ Vascular and Biliary Stent 8 mm x 60 mm (80 cm delivery catheter) · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519009384), received between Jun 8, 2017 and Mar 24, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
- Positioning Failure1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY PARTIALLY OPENED AS THE INNER PLASTIC OF THE DEVICE SEEMINGLY WASN¿T SECURED PROPERLY. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT USED AS IT WAS TECHNICALLY UNSTERILE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16609193 ↗MalfunctionJun 8, 2017Positioning Failure; Device Operates Differently Than Expected; Positioning Failure; Device Operates Differently Than Expected
IT WAS REPORTED THAT DURING ADVANCEMENT INTO THE LESION IN THE RIGHT EXTERNAL ILIAC, RESISTANCE WAS FELT AND DURING AN ATTEMPT TO DEPLOY THE STENT NOTCH WOULD NOT LOCK. IT WAS ATTEMPTED TO MANUALLY DEPLOY THE STENT WITH UNSUCCESSFUL RESULTS; THEREFORE, THE DELIVERY SYSTEM WAS REMOVED AND UPON REMOVAL THE STENT ELONGATED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6622685 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Absolute Pro 1012536-100Abbott Vascular Inc. · STENT, ILIAC21 reports
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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