LifeStent® XL Vascular & Biliary Stent EX071503CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04049519001326), received between Oct 6, 2015 and Jun 8, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Misfire

  ON (B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTENT. IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND THEN ALLEGEDLY JUST STOPPED DEPLOYING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25423667 ↗
• MalfunctionNov 18, 2025Break; Fracture; Misfire; Break; Fracture; Misfire

  ON (B)(6) 2025.A 65-YEAR-OLD FEMALE PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT. DURING THE PROCEDURE, THE THUMB WHEEL AND PULL GRIP MALFUNCTIONED GOT PARTIAL DEPLOYMENT. FURTHER, THE PHYSICIAN NOTED THE STENT HOUSING MAY HAVE SHIFTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578825 ↗
• MalfunctionSep 2, 2025Break; Fracture; Difficult to Remove; Material Twisted/Bent; Break; Fracture; Difficult to Remove; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT XL VASCULAR STENT. DURING THE PROCEDURE, THE STENT WAS ALLEGEDLY FRACTURED AT POST-DELIVERY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22931851 ↗
• MalfunctionSep 2, 2025Break; Fracture; Break; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT XL VASCULAR STENT. DURING THE PROCEDURE, THE STENT WAS ALLEGEDLY FRACTURED OUTSIDE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22931540 ↗
• MalfunctionAug 28, 2025Break; Positioning Failure; Break; Positioning Failure

  ON (B)(6) 2025 A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE. DURING THE INSTALLATION, THE LATCH ALLEGEDLY BROKE, AND THE STENT COULD NOT BE RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910906 ↗
• MalfunctionMay 26, 2025Break; Failure to Advance; Break; Failure to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT XL VASCULAR STENT. DURING THE PROCEDURE, THE STENT FAILED TO CROSS THE LESION DUE TO EXTREME CALCIFICATION. UPON TRYING TO CROSS THE LESION THE DEPLOYMENT CATHETER BROKE. THE STENT AND DEPLOYMENT SYSTEM WERE ABLE TO BE REMOVED WITH NOTHING LEFT BEHIND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083150 ↗
• MalfunctionMay 26, 2025Break; Fracture; Difficult to Remove; Misfire; Material Deformation; Break; Fracture; Difficult to Remove; Misfire; Material Deformation

  ON (B)(6) 2025. A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT XL VASCULAR STENT. DURING THE PROCEDURE, THE SYSTEM WOULD NOT RELEASE THE STENT FULLY. THE DEVICE WAS REMOVED WITH A PARTIAL OF THE STENT AND THE OTHER PART DEPLOYED IN THE SFA. DOCTOR WOULD LIKE BOTH STENTS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083144 ↗
• InjuryJul 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT COMMON FEMORAL ARTERY, THE STENT WAS ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED OCCLUSION. REPORTEDLY, THE PATIENT WAS TRANSFERRED TO A VASCULAR SURGEON TO TREAT THE REOCCLUDED SUPERFICIAL FEMORAL ARTERY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 19771123 ↗
• MalfunctionJun 14, 2024Break; Positioning Failure; Fracture; Self-Activation or Keying; Misfire; Break; Positioning Failure; Fracture; Self-Activation or Keying; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL LESION, THE STENT ALLEGEDLY PARTIALLY DEPLOYED ABOUT TWO CENTIMETERS. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FOUND TO BE FRACTURED AT THE TIP WHILE REMOVING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19535017 ↗
• MalfunctionJun 23, 2023Misfire; Malposition of Device; Misfire; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DISTAL STENT TWO TO THREE CM OF THE STENT DEPLOYED AND THEN ALLEGEDLY BECAME STUCK. IT WAS FURTHER REPORTED THAT THE STENT GOT DEPLOYED AFTER USING SLIDE OPTION ON THE SIDE OF THE HANDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189643 ↗
• MalfunctionMar 6, 2023Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN DISTAL LEFT COMMON ILIAC VIA RADIAL ACCESS, THE STENT WAS ALLEGEDLY FRACTURED SHORTLY AFTER DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492838 ↗
• MalfunctionJun 20, 2022Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN A HEAVILY CALCIFIED SFA WITH CONTRALATERAL FEMORAL ACCESS, THE STENT ALLEGEDLY FRACTURED. THEREFORE, ANOTHER MANUFACTURER'S STENT WAS DEPLOYED INSIDE THIS STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742135 ↗
• MalfunctionSep 4, 2021Entrapment of Device; Fracture; Misfire; Entrapment of Device; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT STENT GET CAUGHT AND FRACTURED WHILE REMOVING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426169 ↗
• InjuryMar 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT ONE DAY AFTER PLACEMENT IN THE CALCIFIC SUPERFICIAL FEMORAL ARTERY CONTAINING THROMBUS VIA CONTRALATERAL CALCIFIED COMMON FEMORAL APPROACH, THE STENT WAS FOUND FRACTURED IN TWO PLACES. IT WAS FURTHER REPORTED THAT A STENT GRAFT WAS USED TO RELINE THE FRACTURED AREA OF THE STENT IN AN ADDITIONAL PROCEDURE. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Injury

  MAUDE report 9886898 ↗
• MalfunctionOct 3, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE STENT ALLEGEDLY ELONGATED. IT WAS FURTHER REPORTED THAT THE STENT WAS POST DILATED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9153853 ↗
• MalfunctionMar 20, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ATTEMPT TO TREAT STENOSIS IN THE RIGHT MID-SUPERFICIAL FEMORAL ARTERY (SFA) VIA CONTRALATERAL APPROACH THROUGH THE LEFT FEMORAL ARTERY, THE STENT ALLEGEDLY FORESHORTENED, HOWEVER, IT COVERED THE LESION. REPORTEDLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WAS NO REPORTED PATENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438951 ↗
• InjuryNov 2, 2018Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ATHERECTOMY PROCEDURE VIA SFA ACCESS WITH PRE-DILATATION, THE STENT WAS ALLEGEDLY IDENTIFIED TO BE COMPRESSED AFTER PLACEMENT; THEREFORE, A POST-DILATATION WAS PERFORMED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS READMITTED TO THE HOSPITAL LATER THAT DAY TO TREAT A THROMBOSED LEG AS THE STENT ALLEGEDLY FRACTURED AT THE LOCATION OF THE COMPRESSION IDENTIFIED DURING THE INITIAL PROCEDURE. REPORTEDLY, A THROMBECTOMY WAS PERFORMED AND ANOTHER DEVICE WAS DEPLOYED TO COVER THE FRACTURED STENT. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Thrombosis

  MAUDE report 8035530 ↗
• InjuryOct 6, 2015Device Operates Differently Than Expected

  IT WAS REPORTED THAT IMMEDIATELY AFTER DEPLOYMENT OF THE VASCULAR STENT IN THE SFA, THE STENT WAS FOUND TO BE FORESHORTENED. THE DELIVERY SYSTEM WAS RETRACTED FROM THE PATIENT WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED BY POST-DILATION OF THE VASCULAR STENT TO PREVENT THE STENT FROM FURTHER FORESHORTENING AND PROXIMAL PLACEMENT OF AN ADDITIONAL STENT TO COVER THE LESION COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 5130763 ↗