LIFESTENT® 5F060803CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · LIFESTENT® 5F Vascular Stent System, 6 mm x 80 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741120176), received between Jun 20, 2024 and Sep 28, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Detachment of Device or Device Component4
- Difficult to Remove2
- Migration or Expulsion of Device2
- Difficult to Advance1
- Entrapment of Device1
- Fracture1
Patient problems
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Break; Migration or Expulsion of Device; Detachment of Device or Device Component
Patient problems: Foreign Body In Patient
MAUDE report 50914949 ↗InjuryAug 13, 2025Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT 5F VASCULAR STENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF DEPLOYMENT CATHETER BROKE OFF IN PATIENT UPON STENT DEPLOYMENT. REPORTEDLY, IT WAS UNABLE TO SNARE THE BROKEN PART. THE PATIENT HAD TO BE TAKEN TO OPERATING ROOM AND TIP RETRIEVED SURGICALLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22790799 ↗InjuryAug 22, 2024Break; Migration or Expulsion of Device; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Break; Migration or Expulsion of Device; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA THE LEFT COMMON FEMORAL ARTERY, THE CATHETER ALLEGEDLY HAD RESISTANCE WHILE ADVANCING. IT WAS FURTHER REPORTED THAT THE TIP OF DEPLOYMENT DEVICE ALLEGEDLY DETACHED AND MIGRATED TO THE PATIENT'S DISTAL SUPERIOR FEMORAL ARTERY. FURTHERMORE, THE SYSTEM ALLEGEDLY DID NOT GO IN OR GO OUT SMOOTHLY. REPORTEDLY, THE BROKEN AND MIGRATED PART OF THE DEVICE ALLEGEDLY COULD NOT BE REMOVED AND IS NOW CAGED BETWEEN THE ARTERY WALL WITH THE ADDITIONAL TWO STENTS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 20031705 ↗MalfunctionJun 20, 2024Break; Entrapment of Device; Fracture; Detachment of Device or Device Component; Break; Entrapment of Device; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE AFTER A FINAL ANGIOGRAM WAS TAKEN, THE STENT WAS IDENTIFIED ALLEGEDLY BROKEN OFF DUE TO A KINK ON ANOTHER MANUFACTURER¿S 6FR, 45CM INTRODUCER SHEATH AT THE BIFURCATION ON THE PROFUNDAL AND SFA. IT WAS FURTHER REPORTED THAT THE STENT WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19573610 ↗
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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