LIFESTENT® 5F061203CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741120190), received between Jul 11, 2019 and Sep 30, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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 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.

• InjurySep 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTENT 5F VASCULAR STENT. IT IS REPORTED THAT SHE RECENTLY HAD A FALL AND IS EXPERIENCING PAIN IN THE GROIN AREA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 23177083 ↗
• MalfunctionOct 22, 2020Break; Retraction Problem; Malposition of Device; Break; Retraction Problem; Malposition of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 5F050803CS VASCULAR STENT ALLEGEDLY BREAK, RETRACTION PROBLEM, MATERIAL DEFORMATION AND MALPOSITION PROBLEM. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENTS' AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722733 ↗
• MalfunctionOct 22, 2020Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5F061203CS LIFESTENT 5F VASCULAR STENT SYSTEM ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE (B)(6) YEAR OLD PATIENT'S GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722674 ↗
• MalfunctionOct 14, 2019Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENTS INDICATED THAT MODEL 5F061203CS VASCULAR STENT ALLEGEDLY FORESHORTENED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN A (B)(6) YEAR OLD FEMALE PATIENT, (B)(6) LBS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187028 ↗
• MalfunctionJul 11, 2019Fracture; Fracture

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL 5F061203CS VASCULAR STENT ALLEGEDLY FRACTURED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. HE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783286 ↗