LIFESTENT® 5F061501CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · LIFESTENT® 5F Vascular Stent System, 6 mm x 150 mm (80 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741120756), received between Oct 22, 2020 and Sep 9, 2025 — classified as 4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Deformation2
- Misfire2
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
- Difficult or Delayed Positioning1
- Difficult to Remove1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 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 A LIFE STENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DELIVERY SYSTEM BROKE OFF AND THE BROKEN PART WAS RETRIEVED BY USING SNARE TECHNIQUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001192 ↗MalfunctionJul 29, 2025Difficult or Delayed Positioning; Misfire; Material Deformation; Difficult or Delayed Positioning; Misfire; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT 5F VASCULAR STENT. DURING THE PROCEDURE, THE STENT SIGNIFICANTLY FORESHORTENED AND DIDN¿T APPEAR FULLY DEPLOYED IN THE VESSEL, THOUGH IT WAS ONCE REMOVED. A SECONDARY STENT WAS USED, WHICH ALSO SHOWED MILD FORESHORTENING. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22640134 ↗MalfunctionMar 16, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PLASTIC HANDLE THAT HOUSES THE WHEELS TO UNSHEATH THE STENT WAS CRACKED APART, WHITE TOP SIDE FROM THE BOTTOM GREEN SIDE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16562322 ↗MalfunctionOct 22, 2020Difficult to Remove; Misfire; Device-Device Incompatibility; Difficult to Remove; Misfire; Device-Device Incompatibility
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 5F061501CS VASCULAR STENT ALLEGEDLY EXPERIENCED PARTIAL DEPLOYMENT, MATERIAL DEFORMATION, DEVICE-DEVICE INCOMPATIBILITY AND DIFFICULT TO REMOVE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENT AGE, WEIGHT AND GENDER WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10722675 ↗
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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