LifeStent® XL Vascular & Biliary Stent EX061203CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® XL Vascular and Biliary Stent System 6 mm x 120 mm (130 cm delivery catheter) · Class 3 · Implant
All models of LifeStent XL Vascular & Biliary Stent (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519001289), received between Sep 24, 2018 and Jun 5, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Most reported problems
Device problems
- Material Deformation1
- Obstruction of Flow1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Stenosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2023Positioning Failure; Material Deformation; Positioning Failure; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY KINKED UPON INSPECTION AND THE DEPLOYMENT WHEEL WAS VERY HARD TO ROLL BACK. IT WAS FURTHER REPORTED THAT DEPLOYMENT WAS DISCONTINUED AND CATHETER WAS REMOVED FROM BODY WITHOUT INCIDENT. REPORTEDLY, THE STENT WAS DEPLOYED ON THE BACK TABLE WITH NOTICEABLE DEFORMITY TO THE RETRACTING SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17057426 ↗InjurySep 24, 2018Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ONE MONTH POST STENT PLACEMENT, DUPLEX ULTRASOUND DEMONSTRATED INSTENT STENOSIS. NO REPORTED INTERVENTION WAS PERFORMED. THE CURRENT PATIENT STATUS IS UNKNOWN. NEW INFORMATION: IT WAS REPORTED THROUGH CLINICAL TRIAL, APPROXIMATELY EIGHT-MONTH POST INDEX PROCEDURE, ANGIOPLASTY WAS PERFORMED AND IDENTIFIED 90% STENOSIS AT THE TARGET LESION. IT WAS FURTHER REPORTED THAT A SENT GRAFT WAS PLACED TO TREAT THE LESION.
Patient problems: Stenosis
MAUDE report 7903785 ↗
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 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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