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LifeStent® Vascular & Biliary Stent EX060403CSRecalls & reported problems

Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® Vascular and Biliary Stent System 6 mm x 40 mm (130 cm delivery catheter) · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049519001197), received between Oct 4, 2016 and Dec 13, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

Most reported problems

Device problems

  • Failure to Advance2
  • Adverse Event Without Identified Device or Use Problem1
  • Positioning Problem1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT POST STENT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGY IN HER ANKLES AND EYES. IT IS UNKNOWN WHETHER ANY ADDITIONAL MEDICATION OR INTERVENTIONS WERE PROVIDED. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15969562 ↗
  • InjuryMar 14, 2017Failure to Advance; Positioning Problem; Failure to Advance; Positioning Problem

    IT WAS REPORTED THAT THE STENT WAS USED UNSUCCESSFULLY TO OPEN A TWISTED STENT IN THE PROXIMAL SFA. REPORTEDLY, THE DELIVERY SYSTEM COULD NOT CROSS THE TWISTED AREA AND WAS REMOVED. POST-DILATION WITH A PTA BALLOON (SIZE 6 X 40 MM) WAS PERFORMED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE STENT WAS PATENT AFTER POST-DILATION AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT CONCERNING PATIENT (B)(6).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6403594 ↗
  • MalfunctionOct 4, 2016Failure to Advance; Failure to Advance

    IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM COULD ONLY BE ADVANCED HALF WAY THROUGH THROUGH A 6 F INTRODUCER SHEATH OVER A 0.014"' GUIDE WIRE. THEREFORE, THE DELIVERY SYSTEM WAS REMOVED FROM THE INTRODUCER SHEATH OVER THE GUIDE WIRE WITHOUT ISSUE. ANOTHER INTRODUCER SHEATH WAS USED WITH A ANOTHER DEVICE TO PERFORM THE PROCEDURE BY USING THE SAME ACCESS. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5995955 ↗

Other STENT, SUPERFICIAL FEMORAL ARTERY devices

All STENT, SUPERFICIAL FEMORAL ARTERY devices →

Sources and updates

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