LifeStent® XL Vascular Stent EX061703CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04049519000961), received between Feb 10, 2016 and Sep 10, 2025 — classified as 6 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjurySep 18, 2018Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY TWISTED AT THE PROXIMAL END AFTER DEPLOYMENT IN THE LEFT SFA VIA LEFT COMMON FEMORAL. IT WAS FURTHER REPORTED THAT AN ADDITIONAL INTERVENTION WAS PERFORMED TO REMOVE THE STENT. THE PATIENT WAS DOING WELL AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; Vascular System (Circulation), Impaired

  MAUDE report 7887629 ↗
• InjuryAug 31, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY TWELVE MONTHS POST STENT PLACEMENT IN THE FEMORAL ARTERY, ROUTINE DUPLEX ULTRASOUND DEMONSTRATED IN-STENT STENOSIS. ROUTINE DUPLEX ULTRASOUND ALSO DEMONSTRATED IN-STENT STENOSIS DURING THE SUBJECT'S TWENTY-FOUR AND THIRTY-SIX MONTH FOLLOW UPS. THERE WAS NO REPORTED INTERVENTION PERFORMED. THE PATIENT COMPLETED THE STUDY; THEREFORE, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 7839875 ↗
• InjuryJan 12, 2018Fracture; Fracture

  IT WAS REPORTED THAT TEN DAYS AFTER A STENT WAS DEPLOYED TO TREAT AN OCCLUDED VESSEL IN THE LEFT SUPERFICIAL ARTERY, THE STENT ALLEGEDLY FRACTURED. REPORTEDLY, ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE THROMBUS IN ORDER TO SUCCESSFULLY PLACE ANOTHER DEVICE. FURTHERMORE, THE NEW DEVICE WAS PLACED BY OVERLAPPING THE FRACTURED STENT AND ALSO COVERING THE PROXIMAL END OF THE LEFT SUPERFICIAL FEMORAL ARTERY. AS A RESULT, THE PATIENT'S FLOW IS STABILIZED AND THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Reocclusion; Thrombus

  MAUDE report 7188113 ↗
• MalfunctionSep 18, 2017Material Torqued; Material Twisted/Bent; Material Torqued; Material Twisted/Bent

  IT WAS REPORTED THAT THE STENT ALLEGEDLY TWISTED AFTER DEPLOYMENT IN THE SLIGHTLY CALCIFIED LEFT SFA TRACKING ANATOMY; THEREFORE, A BALLOON EXPANDABLE STENT WAS USED TO EXPAND THE TWISTED SECTION. THERE WAS NO REPORTED DIFFICULTY ADVANCING NOR RETRACTING THE DELIVERY SYSTEM, AND THE STENT WAS SUCCESSFULLY DEPLOYED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6874392 ↗
• MalfunctionApr 13, 2017Material Torqued; Material Twisted/Bent; Material Torqued; Material Twisted/Bent

  IT WAS REPORTED THAT ONE YEAR POST IMPLANTATION OF THE VASCULAR STENT IN THE DISTAL SFA, THE STENT WAS FOUND TO BE TWISTED ON X-RAY IMAGING. AS REPORTED, THE BLOOD FLOW IS STILL PRESENT UP TO AND BEHIND THE TWISTED AREA. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6489300 ↗
• MalfunctionJun 8, 2016Partial Blockage; Break; Positioning Failure; Break

  IT WAS REPORTED THAT DURING PLACEMENT IN THE SFA, THE DELIVERY SYSTEM BECAME BLOCKED AND THE VASCULAR STENT COULD NOT BE DEPLOYED. THE DELIVERY SYSTEM WAS RETRACTED FROM THE PATIENT WITHOUT ISSUE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5706467 ↗
• MalfunctionFeb 10, 2016Difficult to Remove; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT AFTER SUCCESSFUL PLACEMENT OF THE VASCULAR STENT IN THE SFA, THE DELIVERY SYSTEM GOT STUCK ON THE 0.035 INCH GUIDE WIRE DURING REMOVAL. THE GUIDE WIRE AND DELIVERY SYSTEM WERE REMOVED AS ONE UNIT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5428053 ↗