LifeStent® Vascular & Biliary Stent System EX050303CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® Vascular and Biliary Stent System 5 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 04049519007854), received between Aug 22, 2017 and Aug 22, 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
- Detachment of Device or Device Component1
- Positioning 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.
MalfunctionAug 22, 2017Break; Detachment of Device or Device Component; Positioning Problem; Break; Detachment of Device or Device Component; Positioning Problem
IT WAS REPORTED THAT DURING TREATMENT IN A HEAVY CALCIFIED VESSEL IN THE SFA AS THE HEALTH CARE PROVIDER WAS ADVANCING; THE DELIVERY SYSTEM BECAME SLIGHTLY STUCK WITH THE GUIDEWIRE AND THE TIP OF THE STENT DELIVERY SYSTEM DETACHED, TRAVELED, AND REMAINS IN THE OCCLUDED PERONEAL ARTERY. REPORTEDLY, THE STENT WAS SUCCESSFULLY DEPLOYED, AND THE HEALTH CARE PROVIDER DETERMINED NOT TO REMOVE THE DETACHED TIP AS IT IS NO HEALTH HAZARD TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6812454 ↗
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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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