LifeStar Vascular & Biliary StentRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 10 models of LifeStar Vascular & Biliary Stent by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2015 and Mar 26, 2026 — classified as 2 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LifeStar Vascular & Biliary Stent problems
Device problems
- Activation Failure4
- Component Misassembled4
- Device Dislodged or Dislocated4
- Failure to Advance3
- Premature Activation3
- Break2
- Device Operates Differently Than Expected2
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient3
- No Patient Involvement1
- Vascular System (Circulation), Impaired1
LifeStar Vascular & Biliary Stent models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LifeStar® Vascular & Biliary Stent VIUS09060STENT, ILIAC4 reports
- LifeStar® Vascular & Biliary Stent VIUS10060STENT, ILIAC4 reports
- LifeStar® Vascular & Biliary Stent VIUS08040CATHETER, BILIARY, DIAGNOSTIC3 reports
- LifeStar® Vascular & Biliary Stent VIUS08060STENT, ILIAC3 reports
- LifeStar® Vascular & Biliary Stent VIUS07040CATHETER, BILIARY, DIAGNOSTIC2 reports
- LifeStar® Vascular & Biliary Stent VIUS07060CATHETER, BILIARY, DIAGNOSTIC2 reports
- LifeStar® Vascular & Biliary Stent VIUS08080STENT, ILIAC2 reports
- LifeStar® Vascular & Biliary Stent VIUL08080STENT, ILIAC1 report
- LifeStar® Vascular & Biliary Stent VIUS08020CATHETER, BILIARY, DIAGNOSTIC1 report
- LifeStar® Vascular & Biliary Stent VIUS10040CATHETER, BILIARY, DIAGNOSTIC1 report
Recent LifeStar Vascular & Biliary Stent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Premature Activation; Failure to Advance; Device-Device Incompatibility
ON (B)(6) 2026, A 69-YEAR-OLD MALE PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTAR BILIARY STENT SYSTEM. DURING THE PROCEDURE, THE STENT GOT STUCK ON THE WIRE AND WOULD NOT ADVANCE ON THE WIRE INTO THE SHEATH AND INTO THE PATIENT FOR DEPLOYMENT. REPORTEDLY, AFTER WIPED DOWN THE WIRE AND FLUSHED THE LIFESTAR CATHETER AS USUAL, BUT IT BECAME STUCK ON THE WIRE THE STENT STARTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24695678 ↗MalfunctionOct 30, 2025Misfire; Difficult to Advance; Misfire; Difficult to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTAR VASCULAR STENT. DURING THE PROCEDURE, STENT DID NOT DEPLOY FULLY, ONLY PARTIALLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23422339 ↗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 ↗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 MAY-29-2025, 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 22319027 ↗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 22319001 ↗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 ↗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 ↗MalfunctionJul 17, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY WOULDN'T CROSS OVER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17332128 ↗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 ↗MalfunctionJul 26, 2022Premature Activation; Premature Activation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY PREMATURELY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15101680 ↗MalfunctionFeb 8, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE END ALLEGEDLY CURLED UP. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13480639 ↗MalfunctionFeb 27, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT DURING DEPLOYMENT IN A VENOUS ANASTOMOSIS VIA RUA GRAFT ACCESS, THE STENT ALLEGEDLY JUMPED. IT WAS FURTHER REPORTED THAT ANOTHER STENT WAS USED TO PIN THE STENT IN PLACE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9764292 ↗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 ↗MalfunctionMay 17, 2018Activation Failure; Activation Failure
IT WAS REPORTED THAT DURING A BILIARY STENT DEPLOYMENT PROCEDURE, THE STENT DEPLOYED BUT ALLEGEDLY WOULD NOT EXPAND. REPORTEDLY, ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7522920 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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