LifeStent® Vascular & Biliary Stent EX060303CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® Vascular and Biliary Stent System 6 mm x 30 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 04049519001180), received between Oct 18, 2019 and Oct 18, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult 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
- Difficult to Advance1
- Difficult to Remove1
- Failure to Advance1
- Premature Activation1
Patient problems
- No Consequences Or Impact To Patient1
- 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.
MalfunctionOct 18, 2019Premature Activation; Difficult to Remove; Failure to Advance; Difficult to Advance; Premature Activation; Difficult to Remove; Failure to Advance; Difficult to Advance
IT WAS REPORTED THAT DURING TREATMENT OF AN 80%+ OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY VIA HIGHLY TORTUOUS AND CALCIFIED TRACKING VESSEL, CONTRALATERAL APPROACH, THE STENT WAS ADVANCED THROUGH THE INTRODUCER SHEATH, WITHDRAWN, AND RE-INTRODUCED. UPON RE-INSERTION, THE HEALTHCARE PROVIDER (HCP) NOTICED THAT 2-3 TANTALUM MARKERS HAD EMERGED FROM THE DELIVERY SYSTEM AND DECIDED TO WITHDRAW THE DEVICE. UPON RETRACTION, THE TANTALUM MARKERS WERE CAUGHT ON THE HEMOSTATIC VALVE AND THE STENT ALLEGEDLY PREMATURELY DEPLOYED HALFWAY. IT WAS FURTHER REPORTED THAT THE DOCTOR REMOVED THE PARTIALLY DEPLOYED STENT FROM THE VALVE. THE PROCEDURE WAS COMPLETED WITH A PTA BALLOON AND NO ADDITIONAL STENTS WERE USED DUE TO THE DIFFICULTY OF THE ANATOMY. REPORTEDLY, THE OCCLUSION WAS REDUCED TO 20% POST-PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 9211563 ↗
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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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