LifeStent® XL Vascular & Biliary Stent EX061503CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04049519001296), received between Nov 25, 2015 and Sep 13, 2024 — classified as 5 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY STENOSIS, THE STENT ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS USED TO UNTWIST THE BALLOON. HOWEVER, ONCE THE BALLOON WAS DEFLATED, THE STENT ALLEGEDLY GOT TWISTED AGAIN. REPORTEDLY, THE TWISTED STENT WAS REMOVED AND THE PROCEDURE WAS NOT CONTINUED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215274 ↗
• MalfunctionJul 3, 2024Difficult or Delayed Positioning; Failure to Advance; Material Twisted/Bent; Difficult or Delayed Positioning; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, THE STENT STARTED TO DEPLOY FINE BUT MIDWAY THROUGH THE LESION, THE ROTATING WHEEL ALLEGEDLY DID NOT ROLLED OUT SMOOTHLY. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FOUND TO BE TWISTED AND COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19663631 ↗
• MalfunctionFeb 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE LEFT FEMORAL ARTERY CROSSOVER APPROACH, THE STENT ALLEGEDLY FORESHORTENED TO HUNDRED MILLIMETERS OR SHORTER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738564 ↗
• MalfunctionOct 22, 2023Break; Difficult or Delayed Positioning; Break; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA THE LEFT COMMON FEMORAL ARTERY APPROACH, THE STENT ALLEGEDLY HAD A HARD STOP WHILE DEPLOYING; AND THE USER SWITCHED BACK TO THE THUMBWHEEL FOR FINAL DEPLOYMENT OF THE STENT. IT WAS FURTHER REPORTED THAT THE BALLOON CATHETER COULD NOT BE ADVANCED INTO THE SHEATH FOR POST DILATATION BECAUSE THE INNER CATHETER WAS ALLEGEDLY LEFT ON THE GUIDEWIRE. REPORTEDLY, THE SHEATH AND THE RETRACTING PART OF THE STENT CATHETER WERE REMOVED INTACT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982348 ↗
• MalfunctionDec 23, 2022Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16041018 ↗
• MalfunctionSep 8, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY GOT FORESHORTENED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15376807 ↗
• MalfunctionSep 8, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN RIGHT FEMORAL ARTERY, THE STENT ALLEGEDLY GOT FORESHORTENED. IT WAS REPORTED THAT THE STENT ALLEGEDLY FAILED TO EXPAND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15376569 ↗
• MalfunctionNov 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12842051 ↗
• MalfunctionFeb 12, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING TREATMENT OF THE LEFT POPLITEAL VIA RIGHT GROIN ACCESS, THE STENT ALLEGEDLY FAILED TO DEPLOY USING THE THUMBWHEEL METHOD. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700897 ↗
• MalfunctionNov 19, 2019Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST SUCCESSFUL STENT DEPLOYMENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA ACCESS THROUGH THE LEFT FEMORAL ARTERY, AS THE DELIVERY SYSTEM WAS REMOVED OVER THE GUIDEWIRE, THE DELIVERY SYSTEM ALLEGEDLY DETACHED FROM ITSELF ONCE OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9340464 ↗
• MalfunctionNov 18, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA LEFT FEMORAL APPROACH, THE DELIVERY SYSTEM ALLEGEDLY BECAME DETACHED FROM ITSELF OUTSIDE OF THE PATIENT, AFTER THE HEALTHCARE PROVIDER ATTEMPTED TO REMOVE THE STENT FROM THE WIRE. REPORTEDLY, THE STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9337681 ↗
• MalfunctionNov 15, 2018Difficult to Remove; Misfire; Device-Device Incompatibility; Difficult to Remove; Misfire; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN A TORTUOUS AND HEAVILY CALCIFIED SFA, IT WAS ALLEGEDLY DIFFICULT TO TRACK THE DELIVERY SYSTEM THROUGH THE ANATOMY TO THE TARGET LESION. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY PARTIALLY DEPLOYED APPROXIMATELY THREE MILLIMETERS. THE STENT ALONG WITH THE GUIDEWIRE WERE REPORTEDLY REMOVED TOGETHER, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8074514 ↗
• MalfunctionAug 17, 2018Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT IN A TORTUOUS AND CALCIFIED SFA VIA A CONTRALATERAL APPROACH, THE CATHETER ALLEGEDLY BROKE AND THE STENT ELONGATED UPON DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794454 ↗
• InjuryJul 3, 2018Fracture; Obstruction of Flow; Fracture; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY FIVE MONTHS POST STENT PLACEMENT IN THE DISTAL SUPERFICIAL FEMORAL ARTERY, THE SUBJECT REQUIRED ADDITIONAL STENT PLACEMENT WITH AN OVERLAP IN THE TARGET LESION. THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL APPROXIMATELY TWO WEEKS POST TARGET LESION RE-INTERVENTION. APPROXIMATELY TWENTY FOUR MONTHS POST STENT PLACEMENT, X-RAY DEMONSTRATED STENT FRACTURE. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient; Stenosis

  MAUDE report 7658861 ↗
• MalfunctionMay 29, 2018Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH THROUGH RIGHT GROIN. THE GUIDEWIRE BECAME ALLEGEDLY STUCK WITHIN THE DELIVERY SYSTEM AND THE OUTER CATHETER OF THE DELIVERY SYSTEM ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM AND GUIDEWIRE WERE REMOVED AS ONE UNIT RESULTING IN A LOSS OF ACCESS. THEREFORE, ANOTHER GUIDEWIRE WAS USED TO REGAIN ACCESS AND A BALLOON WAS USED TO POST-DILATE THE STENT RESULTING IN A SUCCESSFUL DEPLOYMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7551517 ↗
• MalfunctionMay 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER SUCCESSFULLY PLACING THE VASCULAR STENT IN THE SFA, DURING POST DILATION WITH A 150MM PTA BALLOON, IT WAS IDENTIFIED UNDER FLUOROSCOPY THE VASCULAR STENT APPEARED TO BE ALLEGEDLY LONGER THAN THE PTA BALLOON INDICATED. IT WAS FURTHER REPORTED THAT THE STENT FUNCTIONED ACCORDINGLY AND REMAINS IN THE PATIENT. REPORTEDLY, NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7501343 ↗
• MalfunctionMar 29, 2018Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST STENT DEPLOYMENT DURING REMOVAL OF THE DEVICE FROM THE PATIENT'S BODY, THE HANDLE OF THE DEVICE ALLEGEDLY DETACHED FROM THE CATHETER. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7383795 ↗
• InjuryFeb 21, 2017Material Torqued; Material Twisted/Bent; Material Torqued; Material Twisted/Bent

  IT WAS REPORTED THAT THE STENT APPEARED TO BE TWISTED AFTER DEPLOYMENT IN A PRE-DILATED LESION OF THE RIGHT SFA. AS REPORTED, THERE WERE NO ISSUES DURING THE PLACEMENT OF THE STENT AND THE STENT DELIVERY SYSTEM WAS IN A STRAIGHT SECTION DURING DEPLOYMENT. AN ADDITIONAL STENT WAS PLACED TO REALIGN THE TWISTED STENT AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6345692 ↗
• MalfunctionFeb 7, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN STARTING TO DEPLOY THE STENT IN A PRE-DILATED SFA LESION VIA CFA ACCESS. THE DEVICE WAS REMOVED ANOTHER STENT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6307315 ↗
• InjuryDec 27, 2016Fracture; Material Torqued; Material Twisted/Bent; Fracture; Material Torqued; Material Twisted/Bent

  IT WAS REPORTED THAT DURING STENTING OF A PRE-DILATED LESION IN THE SFA VIA CONTRALATERAL COMMON FEMORAL ARTERY ACCESS, THE STENT TWISTED AND FRACTURED UPON DEPLOYMENT. REPORTEDLY, THE TRACKING ANATOMY WAS NOT TORTUOUS OR CALCIFIED, THE SYSTEM WAS FLUSHED PRIOR TO USE, AND A 6 F INTRODUCER SHEATH WAS USED DURING THE PROCEDURE. THE USER HAD NO DIFFICULTIES IN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LESION. ANOTHER STENT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6204653 ↗
• InjuryNov 29, 2016Fracture; Fracture

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE OF THE SFA, THE STENT FRACTURED IMMEDIATELY DURING DEPLOYMENT. REPORTEDLY, THE LESION WAS POST-DILATED AND TWO ADDITIONAL STENTS WERE PLACED THROUGH THE FRACTURE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6131943 ↗
• MalfunctionOct 24, 2016Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  IT WAS REPORTED THAT DURING STENTING OF A PRE-DILATED LESION IN THE SFA VIA COMMON FEMORAL ARTERY ACCESS, THE STENT COULD NOT BE DEPLOYED. REPORTEDLY, THE TRACKING ANATOMY WAS CALCIFIED AND NOTHING UNUSUAL HAPPENED DURING THE PROCEDURE. 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 6050151 ↗
• InjuryApr 13, 2016Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF A MODERATE TO SEVERE NARROWED LESION WITH VERY HARD CALCIFIED PLAQUE IN THE PROXIMAL SFA, UPON DEPLOYMENT IMAGING DEMONSTRATED THE STENT TO BE APPEARED NARROWED IN THE MID PORTION JUST BELOW THE HEAVILY CALCIFIED PROXIMAL SFA PLAQUE. MAGNIFIED IMAGES DEMONSTRATED THE STENT TO BE APPARENTLY TWISTED UPON ITSELF. SEVERAL ATTEMPTS WERE MADE TO OPEN THE NARROWED/TWISTED STENT SEGMENT BY USING DIFFERENT BALLOON CATHETERS AND GUIDE WIRES. FINALLY, A STENT GRAFT WAS IMPLANTED INSIDE THE PREVIOUSLY PLACED STENT ACROSS THE ENTIRE LESION AND POST-DILATED. FOLLOW-UP IMAGING DEMONSTRATED THE STENT GRAFT TO BE WIDELY PATENT WITH ONLY A MILD NARROWING IN THE MID PORTION, WITH NORMAL DISTAL RUN-OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5573703 ↗
• MalfunctionNov 25, 2015Positioning Failure; Failure to Advance

  IT WAS REPORTED THAT THE STENT COULD NOT BE DEPLOYED IN THE SFA DURING THE STENT PLACEMENT PROCEDURE. THE DELIVERY SYSTEM COULD BE RETRACTED THROUGH THE INTRODUCER SHEATH WITHOUT DIFFICULTY. A SUPPORT CATHETER AND A GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5249407 ↗