LIFESTENT® 5F050603CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · LIFESTENT® 5F Vascular Stent System, 5 mm x 60 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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741120626), received between Nov 19, 2021 and Jan 17, 2024 — classified as 1 injury, 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
- Detachment of Device or Device Component2
- Fracture2
- Difficult to Advance1
- Difficult to Remove1
- Entrapment of Device1
- Material Deformation1
- Misfire1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2024Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY VIA AN UP AND OVER ACCESS, THE CATHETER ALLEGEDLY COULD NOT BE REMOVED FROM THE SHEATH. REPORTEDLY, THE CATHETER, WIRE AND THE SHEATH HAD TO BE REMOVED COMPLETELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18523908 ↗MalfunctionNov 23, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE ONE STRUT AT THE BOTTOM OF THE STENT WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18200019 ↗InjuryAug 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, A PIECE OF DELIVERY SYSTEM WAS ALLEGEDLY BROKE OFF WHEN THEY WERE TRYING TO REMOVE THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THEY WERE NOT ABLE TO SNARE THE PIECE THAT WAS LEFT BEHIND TO REMOVE IT. REPORTEDLY, THEY WERE UNABLE TO GET THE LEFTOVER PIECE THAT WAY, AND THE PATIENT HAD TO BE TAKEN TO SURGERY TO REMOVE IT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17478031 ↗MalfunctionAug 29, 2022Difficult to Remove; Misfire; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Misfire; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT SFA, THE STENT PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15309050 ↗MalfunctionNov 19, 2021Break; Fracture; Difficult to Advance; Break; Fracture; Difficult to Advance
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH CONTRALATERAL CFA TO TREAT CLAUDICATION , THE DEVICE WAS MINIMALLY DIFFICULT TO ADVANCE AND IT WAS FURTHER REPORTED THAT THE OUTER WHITE SHEATH OF THE STENT WAS ALLEGEDLY REMOVED AND SEPARATED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12843817 ↗
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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