LifeStent® Biliary Stent EX080801CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Lifestent® Biliary Stent, 8mm x 80mm (80cm catheter length) · 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 04049519000411), received between Nov 10, 2016 and Nov 10, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
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.
MalfunctionNov 10, 2016Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING STENTING OF A PRE-DILATED LESION IN THE AXILLIARY VEIN VIA ACCESS THROUGH THE LOOP OF A GRAFT, THE BILIARY STENT COULD NOT BE DEPLOYED BY ROTATING THE THUMBWEEL OF THE DEPLOYMENT MECHANISM. REPORTEDLY, THERE WAS NO PARTIAL RELEASE OF THE STENT AND THE DELIVERY SYSTEM COULD BE RETRACTED WITHOUT ISSUES. ANOTHER STENT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6094084 ↗
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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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