LifeStent® XL Vascular & Biliary Stent System EX051203CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® XL Vascular and Biliary Stent System 5 mm x 120 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 04049519007939), received between Sep 8, 2017 and Sep 8, 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
- Difficult to Advance1
- 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.
MalfunctionSep 8, 2017Break; Premature Activation; Difficult to Advance; Break; Premature Activation; Difficult to Advance
IT WAS REPORTED THAT DURING ADVANCEMENT OVER THE GUIDEWIRE TO THE RIGHT SFA VIA A CONTRALATERAL APPROACH ALLEGED RESISTANCE WAS FELT, AND A POP SOUND WAS FELT AS IF THE SYSTEM CAME LOOSE FROM THE HANDLE GRIP. REPORTEDLY, THE TRACKING VESSEL WAS CALCIFIED AND THE LESION WAS NOT PRE DILATED. THE STENT COULD BE DEPLOYED WITHOUT EXCESSIVE FORCE AND THE SYSTEM COULD BE WITHDRAWN WITHOUT DIFFICULTY. REPORTEDLY, ANOTHER STENT DELIVERY SYSTEM WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6853289 ↗
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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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