LifeStent® Biliary Stent EX080603CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Lifestent® Biliary Stent, 8mm x 60mm (130cm catheter length) · Class 2 · Implant
Data updated Oct 16, 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 04049519000404), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.
Most reported problems
Device problems
- Difficult to Remove1
- Material Deformation1
- Misfire1
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.
MalfunctionOct 19, 2018Difficult to Remove; Misfire; Material Deformation; Difficult to Remove; Misfire; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT DEPLOYMENT MECHANISM ALLEGEDLY JAMMED BEFORE THE STENT WAS FULLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE PARTIALLY RELEASED STENT COULD BE SEPARATED FROM THE DELIVERY SYSTEM BY USING A HEMOSTAT, WHICH CAUSED THE STENT TO ELONGATE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7987472 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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