LifeStent® Vascular & Biliary Stent EX070401CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® Vascular and Biliary Stent System 7 mm x 40 mm (80 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 04049519001081), received between Jun 14, 2016 and Jun 14, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Packaging Compromised” (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
- Device Packaging Compromised1
- Hole In Material1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- 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.
MalfunctionJun 14, 2016Hole In Material; Tear, Rip or Hole in Device Packaging; Device Packaging Compromised; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PRIOR TO A STENTING PROCEDURE, A HOLE WAS DETECTED IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT; THE DEVICE WAS NOT USED.
Patient problems: No Patient Involvement
MAUDE report 5723242 ↗
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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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