LIFESTENT® 5F071203CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · LIFESTENT® 5F Vascular Stent System, 7 mm x 120 mm (135 cm delivery catheter) · Class 3 · Implant
All models of LIFESTENT (28)
Data updated Oct 16, 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 00801741120350), received between Jan 9, 2025 and Sep 30, 2025 — classified as 1 injury, 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
- Material Deformation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2025Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT 5F, THE STENT DEPLOYED, BUT THE CORE/TIP OF THE DEPLOYMENT SYSTEM DISLODGED INSIDE THE PATIENT. RETRIEVAL ATTEMPTS FAILED, AND THE PATIENT REQUIRED SURGICAL CUTDOWN. THE PATIENT STATUS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 23178039 ↗MalfunctionJan 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY BROKE OFF. IT WAS FURTHER REPORTED THAT THE BROKEN PART OF THE STENT WAS REMOVED USING A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21109052 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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