LIFESTENT® 5F070601CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · LIFESTENT® 5F Vascular Stent System, 7 mm x 60 mm (80 cm delivery catheter) · Class 3 · Implant
All models of LIFESTENT (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741120251), received between Jun 26, 2025 and Jul 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Detachment of Device or Device Component1
- Difficult to Remove1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE IN EXTREMELY DISEASED ARTERY USING THE LIFESTENT 5F VASCULAR STENT. DURING THE PROCEDURE, THE LIFE STENT ALLEGEDLY FRACTURED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22504993 ↗MalfunctionJun 26, 2025Fracture; Difficult to Remove; Malposition of Device; Fracture; Difficult to Remove; Malposition of Device
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE LIFE STENT ALLEGEDLY FRACTURED REPORTED AN UNUSUAL LOUD CRUNCH/POP SOUND DURING THE PROCESS. THERE WAS NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22333932 ↗
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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