LifeStent XL Vascular StentRecalls & reported problems across all models

We found 2 models of LifeStent XL Vascular Stent by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2016 and Sep 10, 2025 — classified as 9 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LifeStent XL Vascular Stent problems

LifeStent XL Vascular Stent models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LifeStent® XL Vascular Stent EX061703CS

  STENT, SUPERFICIAL FEMORAL ARTERY
  19 reports
• LifeStent® XL Vascular Stent EX071703CS

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports

Recent LifeStent XL Vascular Stent adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 10, 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 23013060 ↗
• 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 ↗
• InjuryMar 26, 2025Break; Fracture; Misfire; Detachment of Device or Device Component; Break; Fracture; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED DURING A STENT PLACEMENT PROCEDURE, THE STENT HAD ALLEGEDLY FLOWERED AND STOPPED DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE DISTAL PORTION OF THE STENT AND THE DELIVERY SYSTEM WAS ALLEGEDLY BROKEN IN THE INTRODUCER SHEATH. REPORTEDLY, THE BROKEN PIECES OF THE NOSE CONE AND STENT WAS ALLEGEDLY STUCK ON THE WIRE. FURTHERMORE, THE PATIENT'S SUPERFICIAL FEMORAL ARTERY DAMAGE WAS ALLEGEDLY DUE TO DRAGGING PARTIALLY DEPLOYED STENT OUT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 21694656 ↗
• 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 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT FEMORAL ARTERY, THE DEVICE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15585929 ↗
• MalfunctionSep 20, 2022Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE STENT ALLEGEDLY FORESHORTENED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453790 ↗
• InjuryMar 16, 2022Fracture; Obstruction of Flow; Misfire; Material Twisted/Bent; Activation Failure; Fracture; Obstruction of Flow; Misfire; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY, THE DEVICE ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT THE CENTRAL PART OF THE DEVICE DID NOT FULLY DEPLOY AND BECAME CRIMPED UPON REMOVAL. REPORTEDLY, THE PATIENT VESSEL OCCLUDED AND WAS TREATED WITH THROMBOLYTICS. THE PATIENT ALSO UNDERWENT SERIAL DILATION AND RE-STENTING. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13788572 ↗
• MalfunctionApr 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY FRACTURED WHILE ADVANCING THROUGH SHEATH. IT WAS FURTHER REPORTED THAT SAME STENT WAS DEPLOYED WITH OUT ANY COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692418 ↗
• MalfunctionApr 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY FRACTURED WHILE ADVANCING ON CATHETER THROUGH SHEATH. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692374 ↗
• MalfunctionApr 20, 2021Break; Positioning Failure; Fracture; Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY AND THE SHEATH WAS FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692180 ↗
• MalfunctionApr 20, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE CATHETER WAS FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691564 ↗
• MalfunctionApr 19, 2021Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT, THE STENT ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686039 ↗
• MalfunctionApr 24, 2019Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE STENT PLACEMENT, THE DELIVERY SYSTEM, THE STENT, AND THE GUIDEWIRE ALLEGEDLY GOT STUCK ON EACH OTHER CAUSING THE STENT TO COME OFF OF THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545357 ↗
• MalfunctionMar 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE STENT PLACEMENT FOR AN OCCLUSION OF THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA), THE TIP OF THE DELIVERY CATHETER ALLEGEDLY DETACHED FROM THE DELIVERY SYSTEM AFTER DEPLOYMENT. FURTHERMORE, THE TIP OF THE DELIVERY CATHETER REMAINED ON THE SHEATH OVER THE GUIDEWIRE. REPORTEDLY, A NEW DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417665 ↗
• 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 ↗

Other Bard Peripheral Vascular, Inc. products

• MAX-CORE11 models · 8,845 reports · 1 recall
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• MAGNUM19 models · 571 reports · 1 recall
• Conquest32 models · 560 reports
• Ultraverse RX56 models · 536 reports
• Fluency Endovascular Stent Graft51 models · 532 reports
• Atlas Gold33 models · 427 reports
• Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports