LifeStent® Biliary Stent EX100603CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Lifestent® Biliary Stent, 10mm x 60mm (130cm 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 04049519000602), received between Nov 21, 2016 and Nov 21, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
- Premature Activation1
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.
MalfunctionNov 21, 2016Premature Activation; Failure to Advance; Premature Activation; Failure to Advance
IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE GUIDE WIRE FAILED TO PASS THROUGH THE STENT DELIVERY SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE RETURNED DEVICE, THE STENT WAS FOUND TO BE PARTIALLY RELEASED 1MM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Patient Involvement
MAUDE report 6116636 ↗
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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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