LifeStent® XL Vascular Stent EX071703CSRecalls & reported problems
Bard Peripheral Vascular, Inc. · BARD® LIFESTENT® XL Vascular Stent System 7 mm x 170 mm (130 cm delivery catheter) · Class 3 · Implant
All models of LifeStent XL Vascular Stent (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04049519001005), received between Nov 14, 2016 and Sep 9, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Material Twisted/Bent4
- Material Torqued2
- Activation Failure1
- Activation, Positioning or Separation Problem1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient2
- Claudication1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Obstruction/Occlusion1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Fracture; Obstruction of Flow; Material Twisted/Bent; Fracture; Obstruction of Flow; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT XL VASCULAR STENT. ON (B)(6) 2025 THE PATIENT CAME FOR POST-PROCEDURAL CHRONIC LIMB ISCHEMIA WITH SEVERE PAIN. AFTER FURTHER EVALUATION, IT WAS REPORTED THAT THE STENT WAS ALLEGEDLY FRACTURED WHICH RESULTS IN OCCLUSION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Obstruction/Occlusion; Pain
MAUDE report 23001570 ↗MalfunctionJul 3, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FRACTURED IMMEDIATELY AFTER DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17244771 ↗MalfunctionNov 1, 2018Fracture; Material Twisted/Bent; Activation Failure; Fracture; Material Twisted/Bent; Activation Failure
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE FOR STENOSIS AT THE END OF AN EPTFE BYPASS GRAFT IN THE PROXIMAL POPLITEAL, THE STENT ALLEGEDLY FAILED TO EXPAND AND FRACTURED IN TWO LOCATIONS. IT WAS FURTHER REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO EXPAND THE FRACTURED STENT USING PTA BALLOONS UNSUCCESSFULLY. THEREFORE, TWO BALLOON EXPANDABLE COVERED STENTS WERE DEPLOYED WITHIN THE ALLEGED COMPRESSED AND FRACTURED STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8031276 ↗InjuryFeb 7, 2018Fracture; Material Torqued; Material Twisted/Bent; Fracture; Material Torqued; Material Twisted/Bent
IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST OVERLAPPING STENT PLACEMENT IN THE SUPERFICIAL FEMORAL ARTERY, THE STENT IN PROXIMAL POSITION ALLEGEDLY HAD MULTIPLE FRACTURES. IT WAS FURTHER REPORTED, THE PATIENT RETURNED WITH REOCCURRING SYMPTOMS (CLAUDICATION) WHICH MAY HAVE REQUIRED MEDICAL INTERVENTION. CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Claudication; No Known Impact Or Consequence To Patient
MAUDE report 7249158 ↗InjuryNov 14, 2016Activation, Positioning or Separation Problem; Material Torqued; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Torqued; Material Twisted/Bent
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE USER EXPERIENCED DIFFICULTIES IN THE MIDDLE OF DEPLOYMENT. ON THE IMAGE TAKEN POST DEPLOYMENT, THE VASCULAR STENT WAS FOUND TO BE COMPLETELY TWISTED IN THE MIDDLE SECTION. IN ORDER TO OPEN THE TWISTED VASCULAR STENT, A STENT GRAFT WAS PLACED INSIDE THE STENT IMMEDIATELY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6099068 ↗
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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