LIFESTENT® 5F051503CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741120664), received between Jan 9, 2020 and May 13, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Break; Detachment of Device or Device Component; Difficult to Advance

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTENT DEVICE. IT WAS REPORTED THAT THE NOSE CONE OF THE STENT DETACHED AFTER DEPLOYMENT. THE CATHETER FRAGMENTS WERE SUBSEQUENTLY RETRIEVED FROM THE PATIENT¿S BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157848 ↗
• MalfunctionNov 3, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT WITH LIFESTENT VASCULAR STENT. DURING THE PROCEDURE WHEN IT WAS PLACED IN THE PATIENT IT WAS FOUND THAT THE LENGTH OF THE STENT WAS NOT ACCURATE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447441 ↗
• InjuryNov 19, 2024Fracture; Obstruction of Flow; Fracture; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR, NINE MONTHS AND SIXTEEN DAYS STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FRACTURED AND PATIENT ALLEGEDLY EXPERIENCED RESTENOSIS. HOWEVER, THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 20721700 ↗
• MalfunctionApr 11, 2024Fracture; Difficult to Remove; Misfire; Material Deformation; Fracture; Difficult to Remove; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT POPLITEAL ARTERY VIA THE LEFT COMMON FEMORAL ARTERY, THE STENT ALLEGEDLY DIDN'T FULLY DEPLOY AS ONLY ONE TO TWO CENTIMETERS OF THE PROXIMAL END OF THE STENT GOT DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085880 ↗
• MalfunctionMar 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, WHILE REMOVING THE CATHETER, THE CATHETER ALLEGEDLY GOT SNAPPED IN HALF INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE PIECE THAT HOLDS THE CATHETER TO THE STENT WAS ALLEGEDLY BROKEN. REPORTEDLY, THE CATHETER WAS PULLED OUT WITH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966715 ↗
• MalfunctionAug 31, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT GO THROUGH THE INTRODUCER SHEATH FROM A PEDAL ARTERY ACCESS SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17659090 ↗
• 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 15110782 ↗
• MalfunctionApr 13, 2022Break; Difficult to Remove; Device-Device Incompatibility; Break; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY STUCK IN THE DELIVERY SYSTEM AND THEN GUIDEWIRE WAS ALLEGEDLY NOT ABLE TO BE REMOVED, STENT COULDN'T DEPLOY. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM HAD THE THUMB WHEEL WAS ALLEGEDLY BROKEN. REPORTEDLY, THE HEALTH CARE PROVIDED HAD TO REMOVE THE GUIDEWIRE AND THE DELIVERY SYSTEM AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14098056 ↗
• MalfunctionJan 9, 2020Misfire; Material Deformation; Misfire; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5F051503CS VASCULAR STENT ALLEGEDLY EXPERIENCED MISFIRE AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THERE WERE NO CONSEQUENCES TO THE ONE PATIENT INVOLVED. THE PATIENT WAS REPORTED AS A (B)(6) YEAR OLD MALE WEIGHING (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9570157 ↗