LifeStent® Vascular & Biliary Stent EX070403CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® Vascular and Biliary Stent System 7 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 04049519001241), received between Mar 24, 2016 and Apr 27, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Fracture1
- Improper or Incorrect Procedure or Method1
- Mechanical Jam1
- Obstruction of Flow1
- Occlusion Within Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Occlusion1
- Reocclusion1
- Stenosis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2022Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DELIVERY SYSTEM HANDLE WAS ALLEGEDLY BROKEN WHILE DEPLOYING. IT WAS FURTHER REPORTED THAT DOCTOR TURNED WHEEL AND FORGOT TO PULL SAFETY PIN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14216849 ↗InjuryJun 9, 2016Fracture; Occlusion Within Device; Obstruction of Flow; Fracture; Occlusion Within Device; Obstruction of Flow
IT WAS REPORTED THAT 9 MONTHS POST PLACEMENT OF TWO OVERLAPPING STENTS IN THE SFA, THE STENTED SECTION WAS FOUND TO BE RESTENOSED AND POSSIBLY FRACTURED. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS TREATED WITH A MEDICAL THERAPY. THERE WAS NO REPORTED PATIENT INJURY. THIS COMPLAINT ADDRESSES THE DISTAL STENT AND CONCERNS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00160.
Patient problems: Occlusion; Reocclusion; Stenosis
MAUDE report 5708604 ↗MalfunctionMar 24, 2016Break; Mechanical Jam
IT WAS REPORTED THAT DURING A STENTING PROCEDURE OF THE LOWER LEG, UPON INSERTION THE DELIVERY SYSTEM GOT CAUGHT ON A PREVIOUSLY IMPLANTED EXTERNAL ILIAC STENT DURING TRANSIT TO THE TARGET LESION. THE DELIVERY SYSTEM WITH THE UNDEPLOYED STENT WAS RETRACTED AND REPORTEDLY, THE TIP OF THE DELIVERY SYSTEM APPEARED TO BE DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5522976 ↗
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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