LifeStar® Vascular & Biliary Stent VIUS10060Recalls & reported problems
Bard Peripheral Vascular, Inc. · LifeStar™ Vascular and Biliary Stent System 10 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519005553), received between Mar 21, 2017 and Jun 24, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (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
- Component Misassembled2
- Device Dislodged or Dislocated2
- Activation Failure1
- Difficult or Delayed Positioning1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025Device Dislodged or Dislocated; Component Misassembled; Device Dislodged or Dislocated; Component Misassembled
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTAR VASCULAR STENT. DURING THE PROCEDURE, IT CAME TO NOTICE THAT THE RADIOPAQUE MARKER WAS NOT IN THE CORRECT LOCATION ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319029 ↗MalfunctionJun 24, 2025Device Dislodged or Dislocated; Component Misassembled; Device Dislodged or Dislocated; Component Misassembled
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTAR VASCULAR STENT. DURING THE PROCEDURE, IT CAME TO NOTICE THAT THE RADIOPAQUE MARKER WAS NOT IN THE CORRECT LOCATION ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319000 ↗MalfunctionApr 26, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF A PRE-DILATED UPPER AXILLARY A/V GRAFT STENOSIS, IT WAS DIFFICULT TO DEPLOY THE STENT. DURING THE ATTEMPT TO RETRACT THE Y ADAPTER RESISTANCE WAS EXPERIENCED; HOWEVER, THE STENT COULD BE DEPLOYED SUCCESSFULLY AT THE TARGET SITE WITHOUT FURTHER ISSUES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6522362 ↗InjuryMar 21, 2017Activation Failure; Activation Failure
IT WAS REPORTED THAT ONE END OF THE STENT DID NOT SELF-EXPAND AFTER DEPLOYMENT IN THE BRACHIAL VEIN FOR TREATMENT OF A STENOSIS IN AN A/V FISTULA. A BALLOON CATHETER WAS USED TO EXPAND THE STENT COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6422228 ↗
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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