LIFESTENT® 5F060603CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741120169), received between Jul 23, 2018 and Jul 1, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE RED TRIGGER BUTTON ALLEGEDLY BROKE OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642527 ↗
• MalfunctionApr 15, 2024Break; Positioning Failure; Material Separation; Break; Positioning Failure; Material Separation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE FEMORAL ACCESS, THE DEVICE LOCK BUTTON ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106723 ↗
• MalfunctionSep 14, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. UPON REMOVING THE STENT SYSTEM, THE TIP ALLEGEDLY BROKE OFF IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468030 ↗
• InjuryMar 2, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT FEMORAL ARTERY, AN ANGIOGRAM ALLEGEDLY IDENTIFIED TWO FREE FLOWING FOREIGN BODIES IN THE RIGHT COMMON ILIAC ARTERY. THE PATIENT WAS THEN MOVED TO THE OPERATING ROOM FOR OPEN OPERATIVE RETRIEVAL OF THE FOREIGN BODIES WHERE ONE WAS SUCCESSFULLY RETRIEVED AND THE SECOND PIECE WAS UNABLE TO BE RETRIEVED. IT WAS FURTHER REPORTED THAT THE TWO FOREIGN BODIES WERE IDENTIFIED AS FRAGMENTS OF THE DELIVERY SYSTEM THAT ALLEGEDLY BROKE AND DETACHED IN THE PATIENT. THE PATIENT WAS REPORTEDLY STABLE POST REMOVAL PROCEDURE AND DISCHARGED FROM THE HOSPITAL.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9777341 ↗
• MalfunctionJul 23, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A VASCULAR STENT DEPLOYMENT IN THE SFA, USING AN ANTEGRADE APPROACH AND ACCESSING THE LESION THROUGH THE LEFT COMMON FEMORAL ARTERY, THE STENT ALLEGEDLY JUMPED AND WAS IMPLANTED APPROXIMATELY 6CM FROM THE INTENDED PLACEMENT SITE. THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT, AND A SECOND VASCULAR STENT WAS DEPLOYED BUT DURING DEPLOYMENT THE STENT ALSO JUMPED AND WAS IMPLANTED APPROXIMATELY 2CM FROM THE INTENDED PLACEMENT SITE. IT WAS FURTHER REPORTED THAT A THIRD VASCULAR STENT WAS SUCCESSFULLY DEPLOYED AT THE INTENDED PLACEMENT SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712717 ↗