LIFESTENT® 5F070603CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741120329), received between Jul 22, 2019 and Oct 25, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT DISTAL BRACHIAL ARTERY VIA THE RIGHT COMMON FEMORAL ARTERY, WHEN THE STENT DELIVERY SYSTEM WAS PLACED ON THE WIRE AND REACHED THE SHEATH VALVE, THE DISTAL END OF THE STENT WAS FOUND TO BE ALREADY OPEN AND APPROXIMATELY ONE CENTIMETER OF THE STENT WAS ALLEGEDLY FOUND TO BE PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18005126 ↗
• InjuryOct 9, 2023Break; Premature Activation; Malposition of Device; Detachment of Device or Device Component; Break; Premature Activation; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, STENT ALLEGEDLY JUMPED BACK. IT WAS FURTHER REPORTED THAT STENT ALLEGEDLY STARTED TO DEPLOY ON ITS OWN OVER THE BIFURCATION. REPORTEDLY THE RED UNLOCK BUTTON WAS NOT RELEASED BUT THE STENT DEPLOYMENT SYSTEM WAS DISLODGED FROM THE CATHETER AND STUCK INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894173 ↗
• MalfunctionJul 22, 2019Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5F070603CS VASCULAR STENT SYSTEM ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCE. THE PATIENT WAS FEMALE AND THE AGE AND WEIGHT WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813761 ↗