LifeStar® Vascular & Biliary Stent VIUL08080Recalls & reported problems
Bard Peripheral Vascular, Inc. · LifeStar™ Vascular and Biliary Stent System 8 mm x 80 mm (135 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
- 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 04049519004938), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure 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.
Reports received per month
Most reported problems
Device problems
- Failure to Advance1
- Premature Activation1
- Self-Activation or Keying1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Premature Activation; Self-Activation or Keying; Failure to Advance; Premature Activation; Self-Activation or Keying; Failure to Advance
ON (B)(6) 2025, A PATIENT PREPPED FOR A STENT PLACEMENT PROCEDURE USING LIFESTAR. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THEY TRIED THE STENT TO LOAD ONTO A WIRE, AND THE WIRE WAS UNABLE TO ADVANCE THROUGH. THEY DIDN'T GET IT ADVANCED ENOUGH TO GO THROUGH THE SHEATH. THEY CHECKED THE TIP OF THE STENT AND NOTICED THAT IT LOOKED WRONG AND WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290257 ↗
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.
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