LIFESTENT® 5F051003CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741120640), received between Dec 19, 2018 and Aug 22, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA LEFT FEMORAL ACCESS, THE COMPONENTS OF THE DEVICE WERE ALLEGEDLY FOUND NOT TO BE INTACT AT THE BASE TOWARDS HANDLE DURING ADVANCEMENT TO THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030574 ↗
• MalfunctionOct 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948220 ↗
• InjuryJun 19, 2023Break; Malposition of Device; Detachment of Device or Device Component; Break; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, A PIECE OF THE DEPLOYMENT DEVICE WAS ALLEGEDLY BREAK OFF AND GOT STUCK IN THE PATIENT. IT WAS FURTHER REPORTED THAT SNARE AND BALLOON WAS USED TO RETRIEVE THE PIECE. REPORTEDLY, PATIENT ENDED UP WITH KNEE AMPUTATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17150480 ↗
• MalfunctionJan 30, 2023Break; 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 THROUGH FEMORAL ARTERY, THE STENT ALLEGEDLY DETACHED INTO PIECES. IT WAS FURTHER REPORTED THAT THERE WAS A LIGHT TENSION WHEN INITIALLY RETRACTING THE STENT FROM DEPLOYMENT LOCATION. REPORTEDLY, THE DETACHED SEGMENTS WERE REMOVED USING SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264018 ↗
• MalfunctionJul 27, 2022Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY HAD A POSITIONING PROBLEM. IT WAS FURTHER REPORTED THAT CATHETER ALLEGEDLY BUCKLED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15110827 ↗
• MalfunctionFeb 16, 2022Material Invagination; Premature Activation; Material Invagination; Premature Activation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT SUPERFICIAL ARTERY (SFA) PROCEDURE THROUGH THE COMMON FEMORAL ACCESS, THE CATHETER TIP ALLEGEDLY PREMATURELY DEPLOYED AS IT WAS BEING ADVANCED ACROSS THE LESION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539797 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT DURING THE STENT PLACEMENT, THE DEVICE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT IT WAS NOT BROKE INSIDE THE PATIENT, HOWEVER IT WAS NOTED AFTER PULLING OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10956836 ↗
• MalfunctionDec 4, 2020Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE INNER CATHETER WAS BROKE INSIDE THE PATIENT AFTER DEPLOYING THE STENT. IT WAS FURTHER REPORTED THAT THE BROKEN PARTICLES REMOVED WITH THE HELP OF SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10947671 ↗
• MalfunctionJul 10, 2020Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 5F051003CS VASCULAR STENT ALLEGEDLY EXPERIENCED DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE FEMALE PATIENT IS (B)(6) AND WEIGHS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10261400 ↗
• MalfunctionDec 19, 2018Difficult to Remove; Misfire; Device-Device Incompatibility; Material Deformation; Difficult to Remove; Misfire; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE INTENDED FOR A CALCIFIED RIGHT FEMORAL ARTERY VIA ACCESS THROUGH THE LEFT FEMORAL ARTERY, THE STENT ALLEGEDLY PARTIALLY DEPLOYED APPROXIMATELY TWO CENTIMETERS USING THE THUMBWHEEL DEPLOYMENT WHEEL. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGED DIFFICULTY REMOVING THE DELIVERY SYSTEM AND THE GUIDEWIRE BECAME STUCK IN THE SYSTEM. ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182102 ↗