LifeStar® Vascular & Biliary Stent VIUS08060Recalls & reported problems
Bard Peripheral Vascular, Inc. · LifeStar™ Vascular and Biliary Stent System 8 mm x 60 mm (80 cm delivery catheter) · Class 3 · Implant
All models of LifeStar Vascular & Biliary Stent (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049519005416), received between Mar 15, 2019 and Jul 8, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Activation Failure2
- Misfire1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2024Activation Failure; Activation Failure
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUBCLAVIAN RESIDUAL STENOSIS VIA THE LEFT ARM, THE DISTAL END OF THE STENT ALLEGEDLY WOULD NOT OPEN. IT WAS FURTHER REPORTED THAT WHEN THE HEALTH CARE PROFESSIONAL TRIED TO BALLOON IT OPEN, THE STENT ALLEGEDLY MADE A LOUD POPPING NOISE. REPORTEDLY, ANOTHER STENT WAS USED TO OVERLAP THE STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19687218 ↗MalfunctionJun 1, 2023Activation Failure; Activation Failure
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT ARM VENOUS ANASTAMOSIS, THE STENT ALLEGEDLY DID NOT FULLY OPENED EVEN AFTER BALLOONING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17037143 ↗MalfunctionMar 15, 2019Positioning Failure; Misfire; Positioning Failure; Misfire
IT WAS REPORTED THAT THE STENT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT, AND A NEW DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8425809 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Absolute Pro 1012536-100Abbott Vascular Inc. · STENT, ILIAC21 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page