LifeStent® XL Vascular & Biliary Stent EX071003CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® XL Vascular and Biliary Stent System 7 mm x 100 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
- 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 04049519001302), received between Jan 11, 2016 and Jun 19, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fracture1
- Material Twisted/Bent1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE STENT ALLEGEDLY APPEARED WRAPPED/TWISTED AFTER FINISHING DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN REWIRED THE STENT AND ATTEMPTED MULTIPLE BALLOON INFLATIONS BUT WAS UNSUCCESSFUL IN UN-KINKING THE STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17151524 ↗MalfunctionAug 13, 2022Premature Activation; Premature Activation
IT WAS REPORTED THAT DURING PREPARATION OF A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY PREMATURELY DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15222493 ↗InjuryAug 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE, X-RAY EXAMINATION REVEALED THAT THE TIP ALLEGEDLY DETACHED INSIDE THE PATIENT. THE PATIENT STATUS WAS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 12280046 ↗MalfunctionJan 11, 2016Fracture
IT WAS REPORTED THAT THE STENT ALLEGEDLY FRACTURED POST DEPLOYMENT IN THE SFA. THE STENT REMAINS IMPLANTED AND NO FURTHER TREATMENT WAS PERFORMED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 5357155 ↗
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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