LifeStent® Vascular & Biliary Stent EX070203CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® Vascular and Biliary Stent System 7 mm x 20 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 04049519001227), received between Nov 11, 2015 and Nov 11, 2015 — 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
- Mechanical Jam1
- Premature Activation1
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 11, 2015Premature Activation; Failure to Advance; Mechanical Jam
IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE IN THE SFA, THE DELIVERY SYSTEM GOT STUCK IN THE VALVE OF A 7 F INTRODUCER SHEATH. DURING REMOVAL OF THE DELIVERY SYSTEM, REPORTEDLY THE VASCULAR STENT CAME OUT OF THE DELIVERY SYSTEM. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5217176 ↗
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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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