LIFESTENT® 5F070803CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · LIFESTENT® 5F Vascular Stent System, 7 mm x 80 mm (135 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741120336), received between Jul 22, 2019 and Nov 11, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation2
- Activation Failure1
- Break1
- Detachment of Device or Device Component1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure
A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING TWO LIFESTENT DEVICES. ALLEGEDLY 7X100 MM LIFESTENT DID NOT EXPAND TO ITS FULL INTENDED LENGTH AND THERE WERE ALSO DEPLOYMENT CHALLENGES WITH THE SECOND STENT 7X80 MM LIFESTENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23519752 ↗MalfunctionSep 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTENT. ALLEGEDLY DURING THE PROCEDURE, THE INNER CATHETER TIP BROKE OFF AFTER SUCCESSFUL STENT DEPLOYMENT. THE DELIVERY TIP WAS SUCCESSFULLY SNARED AND RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22987227 ↗MalfunctionJul 22, 2019Malposition of Device; Material Deformation; Malposition of Device; Material Deformation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5F070803CS VASCULAR STENT SYSTEM ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND MALPOSITION OF THE DEVICE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCE. THE PATIENT WAS FEMALE AND THE AGE AND WEIGHT WERE NOT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8814072 ↗
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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