LifeStent® Biliary Stent EX090803CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Lifestent® Biliary Stent, 9mm x 80mm (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 04049519000527), received between Nov 29, 2016 and Nov 29, 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
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 29, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING PLACEMENT OF THE BILIARY STENT IN A PRE-DILATED LESION OF THE RIGHT COMMON ILIAC ARTERY VIA RIGHT FEMORAL ARTERY ACCESS WITH ANOTHER STENT IN KISSING-STENT TECHNIQUE, A WIRE WAS COMING OUT OF THE SIDE OF THE DELIVERY SYSTEM HANDLE WHEN THE DEPLOYMENT WHEEL WAS BEING MOVED FORWARD. AFTER PUSHING THE WIRE BACK INTO THE HANDLE, THE STENT COULD BE DEPLOYED PROPERLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6131935 ↗
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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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