LifeStent® Solo Vascular Stent EX062003CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 04049519004303), received between Oct 19, 2015 and Mar 6, 2026 — classified as 13 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (35 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 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE BY USING LIFESTENT. IT WAS REPORTED THAT THE STENT ALLEGEDLY DETACHED FROM BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529297 ↗
• MalfunctionFeb 13, 2026Break; Positioning Failure; Fracture; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTENT DEVICE. DURING THE PROCEDURE IT WAS REPORTED THAT THE STENT DID NOT DEPLOY AND BECAME CAUGHT ON THE SHEATH. THE STENT WAS REMOVED FROM THE SHEATH AND TAKEN OUT OF THE PATIENT. THE DISTAL END OF THE STENT WAS FOUND TO BE BROKEN OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332341 ↗
• MalfunctionDec 22, 2025Material Frayed; Premature Activation; Difficult to Advance; Material Frayed; Premature Activation; Difficult to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT SOLO VASCULAR STENT. DURING THE PROCEDURE THE CATHETER DID NOT CROSS THE LESION EASILY. AFTER FINALLY CROSSING, IMAGING OF STENT DIDN¿T LOOK RIGHT. AFTER TAKING STENT OUT TO EXAMINE THEY NOTICED THE SHEATH OF STENT FRAYED AWAY FROM STENT. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861614 ↗
• MalfunctionNov 6, 2025Activation Problem; Activation Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT. PHYSICIAN DESCRIBED AS DEFECTIVE DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484854 ↗
• MalfunctionSep 17, 2025Break; Misfire; Material Deformation; Break; Misfire; Material Deformation

  ON (B)(6) 2025 A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT SOLO STENT. DURING DEPLOYMENT PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY, THE STENT PARTIALLY DEPLOYED AND ELONGATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070431 ↗
• MalfunctionJul 25, 2025Break; Failure to Advance; Break; Failure to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT SOLO STENT. DURING THE PROCEDURE, THE STENT ALLEGEDLY FAILED TO ADVANCE INTO THE SHEATH BY THE SHEATH LOADING ONTO THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606092 ↗
• MalfunctionSep 4, 2024Break; Failure to Advance; Device-Device Incompatibility; Material Deformation; Break; Failure to Advance; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE IN LEFT SUPERIOR FEMORAL ARTERY, THE WIRE ALLEGEDLY CAME OUT OF THE LUMEN ABOVE THE DEPLOYMENT HANDLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137501 ↗
• MalfunctionAug 13, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT GROIN, THE STENT WAS ALLEGEDLY UNABLE TO BE ADVANCED OVER THE WIRE. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY HAD A KINK IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978586 ↗
• InjuryJun 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY TWELVE MONTHS POST A STENT PLACEMENT VIA "CONTRALATERAL" APPROACH, THE STENT ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Stenosis

  MAUDE report 19496732 ↗
• MalfunctionDec 11, 2023Break; Material Frayed; Failure to Advance; Difficult to Advance; Material Deformation; Material Twisted/Bent; Break; Material Frayed; Failure to Advance; Difficult to Advance; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BENT OR FRAYED NEAR THE HANDLE DIRECTLY OUT OF THE PACKAGE. IT WAS FURTHER REPORTED THAT THE WIRE ALLEGEDLY HAD SOME RESISTANCE GOING THROUGH THE CATHETER AND WAS ALLEGEDLY FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299305 ↗
• MalfunctionNov 30, 2023Failure to Advance; Material Deformation; Material Twisted/Bent; Failure to Advance; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT GO ON THE WIRE. IT WAS FURTHER REPORTED THAT THE STENT SHAFT WAS ALLEGEDLY TWISTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236067 ↗
• MalfunctionNov 10, 2022Fracture; Misfire; Detachment of Device or Device Component; Fracture; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY MISFIRED. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769003 ↗
• MalfunctionMay 10, 2022Break; Positioning Failure; Fracture; Migration or Expulsion of Device; Misfire; Malposition of Device; Break; Positioning Failure; Fracture; Migration or Expulsion of Device; Misfire; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY CAME OUT OF THE SHEATH AND ENDED UP IN THE COMMON ILIAC ARTERY OPPOSITE SIDE OF THE ACCESS SIDE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14344239 ↗
• MalfunctionMay 6, 2022Break; Break

  IT WAS REPORTED THAT DURING PREPARATION OF STENT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14302625 ↗
• MalfunctionApr 11, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA COMMON FEMORAL ARTERY, THE STENT WAS ALLEGEDLY PARTIALLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072027 ↗
• MalfunctionNov 1, 2021Break; Fracture; Misfire; Material Deformation; Break; Fracture; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE SHEATH BROKE AND THE STENT ALLEGEDLY PARTIALLY DEPLOYED AND ENDED UP BEING DRAGGED DOWN TO THE AT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726581 ↗
• MalfunctionSep 21, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH LEFT FEMORAL ARTERY, THE STENT ALLEGEDLY CAME OFF WITH THE SHEATH. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507393 ↗
• MalfunctionJul 14, 2020Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EX062003CL VASCULAR STENT ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE (B)(6) MALE PATIENT WAS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10272083 ↗
• MalfunctionJul 14, 2020Premature Activation; Premature Activation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL EX062003CL VASCULAR STENT ALLEGEDLY EXPERIENCED PREMATURE DEPLOYMENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS NOT INVOLVED AS THERE WAS NO PATIENT CONTACT. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10271828 ↗
• MalfunctionJul 16, 2019Break; Fracture; Misfire; Break; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EX062003CL VASCULAR STENT ALLEGEDLY EXPERIENCED A BREAK, MISFIRE, FRACTURE, AND PREMATURE DEPLOYMENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED BREAK, MISFIRE, FRACTURE, AND PREMATURE DEPLOYMENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794091 ↗
• MalfunctionJul 12, 2019Premature Activation; Premature Activation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENTS INDICATED THAT MODEL EX062003CL VASCULAR STENT SYSTEM EXPERIENCED PREMATURE DEPLOYMENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785303 ↗
• MalfunctionMay 28, 2019Fracture; Difficult to Remove; Misfire; Fracture; Difficult to Remove; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE STENT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT AS THE DELIVERY SYSTEM WAS BEING REMOVED FROM THE PATIENT WITH PARTIALLY DEPLOYED STENT, THE STENT ALLEGEDLY FRACTURED. FURTHERMORE, A SECOND STENT WAS USED TO PIN THE FRACTURE SEGMENT AGAINST THE WALL OF THE VESSEL, VIA THE SAME ACCESS SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8647094 ↗
• MalfunctionMar 14, 2019Break; Positioning Failure; Positioning Problem; Break; Positioning Failure; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE TO IMPROVE LUMINAL DIAMETER IN DE NOVO LESION IN A TORTUOUS SFA THROUGH COMMON FEMORAL ACCESS VIA A CONTRALATERAL APPROACH, THE DELIVERY SYSTEM WAS ALLEGEDLY DIFFICULT TO TRACK THROUGH THE ANATOMY TO THE TARGET LESION. FURTHER, THE STENT ALLEGEDLY FAILED TO DEPLOY. THEREFORE, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420888 ↗
• MalfunctionFeb 1, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT UPON REMOVAL FROM THE PACKAGING, A BEND WAS ALLEGEDLY IDENTIFIED TOWARD THE BACK OF THE DELIVERY CATHETER, BUT THE HEALTHCARE PROFESSIONAL DECIDED THAT THE DELIVERY SYSTEM WAS STILL OPERABLE. IT WAS FURTHER REPORTED THAT UPON ADVANCEMENT TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE DELIVERY CATHETER ALLEGEDLY BROKE. THEREFORE, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297825 ↗
• MalfunctionJan 4, 2019Break; Failure to Advance; Device-Device Incompatibility; Break; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT THE VASCULAR STENT DELIVERY SYSTEM WAS ALLEGEDLY UNABLE TO LOAD THROUGH THE 6FR INTRODUCER SHEATH AFTER IT HAD SUCCESSFULLY LOADED THROUGH THE GUIDEWIRE. IT WAS ALSO ALLEGED THE OUTER CATHETER BROKE AS IT WAS INTRODUCED INTO THE 6FR INTRODUCER SHEATH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8218069 ↗