LifeStent® Vascular & Biliary Stent EX060803CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® Vascular and Biliary Stent System 6 mm x 80 mm (130 cm delivery catheter) · 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 04049519001210), received between Sep 5, 2017 and Sep 5, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- 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.
MalfunctionSep 5, 2017Break; Positioning Failure; Break; Positioning Failure
IT WAS REPORTED THAT THE HANDLE OF THE VASCULAR AND BILIARY STENT DELIVERY SYSTEM WAS ALLEGEDLY BROKEN AFTER RESISTANCE WAS FELT DURING DEPLOYMENT IN THE DISTAL SFA VIA A CONTRALATERAL COMMON FEMORAL APPROACH. AS REPORTED THE STENT COULD NOT BE DEPLOYED. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. REPORTEDLY, THE DEVICE WAS EXCHANGED FOR ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6842375 ↗
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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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