LifeStar Biliary StentRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 10 models of LifeStar Biliary Stent by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jan 1, 2016 and Oct 15, 2025 — classified as 5 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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 Biliary Stent problems
Device problems
- Fracture5
- Failure to Advance4
- Premature Activation4
- Material Deformation3
- Break2
- Detachment of Device or Device Component2
- Entrapment of Device2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient6
- Great Vessel Perforation2
- No Patient Involvement2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
LifeStar Biliary Stent models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LifeStar® Biliary Stent VIUS12040CATHETER, BILIARY, DIAGNOSTIC4 reports
- LifeStar® Biliary Stent VIUS10120CATHETER, BILIARY, DIAGNOSTIC3 reports
- LifeStar® Biliary Stent VIUS14080CATHETER, BILIARY, DIAGNOSTIC3 reports
- LifeStar® Biliary Stent VIUL14120CATHETER, BILIARY, DIAGNOSTIC2 reports
- LifeStar® Biliary Stent VIUS14040CATHETER, BILIARY, DIAGNOSTIC2 reports
- LifeStar® Biliary Stent VIUS14060CATHETER, BILIARY, DIAGNOSTIC2 reports
- LifeStar® Biliary Stent VIUL14040CATHETER, BILIARY, DIAGNOSTIC1 report
- LifeStar® Biliary Stent VIUS12080CATHETER, BILIARY, DIAGNOSTIC1 report
- LifeStar® Biliary Stent VIUS12120CATHETER, BILIARY, DIAGNOSTIC1 report
- LifeStar® Biliary Stent VIUS14120CATHETER, BILIARY, DIAGNOSTIC1 report
Recent LifeStar Biliary Stent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2025 A PATIENT UNDERWENT A PLACEMENT OF LIFESTAR STENT ON THE LEFT SIDE OF UNDEFINED ACCESS SITE. PRIOR TO THE PROCEDURE PHYSICIAN LOOKED FOR THE STENTS THAT WERE PLACED IN MONTH OF JULY ONE OF THE STENT HAD MIGRATED UP TO CAVA TOWARDS THE HEART, AND THE PATIENT WAS SENT TO HOSPITAL, AND THE STENT WAS SNARED OUT USING THE SHEATH.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23276232 ↗MalfunctionSep 2, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTAR. DURING THE PROCEDURE THE DEVICE COULDN¿T ADVANCE THROUGH THE COOK SHEATH. THE GUIDEWIRE KINKED, RESULTING IN LOSS OF ACCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929944 ↗MalfunctionMay 28, 2024Misfire; Material Deformation; Misfire; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA PROXIMAL BASILIC VEIN, THE STENT ALLEGEDLY DID NOT DEPLOY COMPLETELY. IT WAS FURTHER REPORTED THAT THE BACK END OF THE STENT ALLEGEDLY DID NOT COME OUT. REPORTEDLY, THE HEALTHCARE PROFESSIONAL TRIED TO PUSH FORWARD THE STENT OUT, BUT IT ENDED UP ELONGATING THE STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19403532 ↗MalfunctionJan 4, 2024Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, DIFFICULT TO PULL BACK WHEN DEPLOYING THE STENT AND THE STENT ALLEGEDLY WOULDN'T FULLY DEPLOY OFF THE CATHETER. IT WAS FURTHER REPORTED THAT THE TOP OF THE STENT WAS OPEN, THE BOTTOM OF THE STENT WAS OPEN, BUT IN THE MIDDLE SEEMED ALL CRUSHED UP. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18442693 ↗MalfunctionJan 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING THE PREPARATION OF A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FOUND TO BE STICKY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423349 ↗MalfunctionNov 27, 2023Misfire; Misfire
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18212130 ↗MalfunctionAug 11, 2021Obstruction of Flow; Detachment of Device or Device Component; Obstruction of Flow; Detachment of Device or Device Component
IT WAS REPORTED THAT POST DEVICE IMPLANT, THE STENT ALLEGEDLY DETACHED INTO A FRAGMENT RESULTING IN DISTAL BOWEL OBSTRUCTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Obstruction/Occlusion
MAUDE report 12305759 ↗InjuryAug 10, 2021Fracture; Migration or Expulsion of Device; Detachment of Device or Device Component; Fracture; Migration or Expulsion of Device; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY BROKE OFF , MIGRATED AND RESULTED IN BOWEL OBSTRUCTION. IT WAS FURTHER REPORTED THAT SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN STENT. THE PATIENT STATUS WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12299627 ↗MalfunctionJun 9, 2021Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE STENT ALLEGEDLY BROKE RESPECTIVELY FRACTURED DURING STENT DEPLOYMENT PROCEDURE IN CEPHALIC VEIN. THERE WAS NO REPORTED INTERVENTION REQUIRED AND THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11965114 ↗InjuryMay 18, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT APPROXIMATELY THREE YEAR AFTER STENT PLACEMENT IN THE RENAL VEINS, THE STENT ALLEGEDLY KINKED AND PROTRUDED THROUGH THE VEIN WALL. IT WAS FURTHER REPORTED THAT THE STENT HAD TO BE REMOVED ALONG WITH SECTIONS OF THE RENAL VEIN DUE TO THE DAMAGE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Great Vessel Perforation; Perforation of Vessels
MAUDE report 10068077 ↗InjuryMay 18, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT APPROXIMATELY THREE YEAR AFTER STENT PLACEMENT IN THE RENAL VEINS, THE STENT ALLEGEDLY KINKED AND PROTRUDED THROUGH THE VEIN WALL. IT WAS FURTHER REPORTED THAT THE STENT HAD TO BE REMOVED ALONG WITH SECTIONS OF THE RENAL VEIN DUE TO THE DAMAGE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Great Vessel Perforation
MAUDE report 10067855 ↗InjuryOct 24, 2019Entrapment of Device; Fracture; Difficult to Remove; Entrapment of Device; Fracture; Difficult to Remove
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUBCLAVIAN VEIN, AFTER STENT PLACEMENT THE STENT GOT CAUGHT ON THE PTA BALLOON, CAUSING THE STENT TO ALLEGEDLY FRACTURE. IT WAS FURTHER REPORTED THAT A NEW DELIVERY SYSTEM WAS USED TO PLACE A NEW STENT INSIDE THE ORIGINAL FRACTURED AND FOLDED STENT. THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9235402 ↗MalfunctionFeb 19, 2019Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation
IT WAS REPORTED THAT AFTER SUCCESSFULLY IMPLANTING THE BILIARY STENT TO TREAT STENOSIS IN A CURVED RIGHT INNOMINATE VEIN VIA ACCESS THROUGH A RIGHT BRACHIOBASILIC FISTULA AND UPON REMOVAL OF THE POST DILATATING PTA BALLOON, THE STENT ALLEGEDLY WAS PULLED BACK WITH THE BALLOON AND COLLAPSED. IT WAS FURTHER REPORTED THAT A STENT GRAFT WAS USED TO COVER THE COLLAPSED STENT AND BALLOON DILATATION WAS PERFORMED TO APOSE THE STENTS TO THE VESSEL WALL. ANOTHER DEVICE WAS USED TO COVER THE TARGET LESION AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8351315 ↗MalfunctionAug 30, 2017Premature Activation; Failure to Advance; Premature Activation; Failure to Advance
IT WAS REPORTED THAT DURING AN ATTEMPT TO ADVANCE THE DELIVERY SYSTEM OVER THE GUIDEWIRE, THE VASCULAR STENT ALLEGEDLY STARTED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM ALLEGEDLY BECAME STUCK ON THE GUIDEWIRE; THEREFORE, EVERYTHING HAD TO BE REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6832824 ↗MalfunctionMar 8, 2017Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE BILIARY STENT COULD NOT BE DEPLOYED. ANOTHER STENT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6387678 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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