E-Luminexx® Vascular & Biliary Stent ZBM07060Recalls & reported problems
Bard Peripheral Vascular, Inc. · Bard® E-LUMINEXX™ Vascular and Biliary Stent 7 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
- 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 04049519009322), received between Jan 14, 2016 and Jan 14, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
- Positioning Failure1
- Sticking1
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.
MalfunctionJan 14, 2016Positioning Failure; Sticking; Activation, Positioning or Separation Problem; Positioning Failure; Sticking; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT THE STENT GOT STUCK IN THE SHEATH WHEN BEING PARTIALLY DEPLOYED AND COULD NOT BE DEPLOYED ANY FURTHER. THEN THE DELIVERY SYSTEM WAS DISASSEMBLED IN ORDER TO DEPLOY THE STENT MANUALLY; HOWEVER, WITHOUT SUCCESS. THE STENT WHICH WAS STILL LOCATED INSIDE THE SHEATH PARTIALLY COULD BE REMOVED WITHOUT ISSUE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5367137 ↗
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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