LIFESTENT® 5F050803CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741120633), received between Mar 9, 2018 and Oct 27, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT. DURING THE PROCEDURE WHEN PHYSICIAN INTRODUCED THE STENT INTO THE SHEATH 5F VIA SUPERFICIAL FEMORAL ARTERY, IT WAS NOTED THAT RESISTANCE OCCURRED. WHEN THE STENT WAS REMOVED OUT OF THE SHEATH, SELF DEPLOYMENT OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388271 ↗
• InjurySep 25, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A FOLLOW UP PROCEDURE, IT WAS DISCOVERED THAT SOME FRAGMENTED PARTS OF THE CATHETER WERE IN THE POPLITEAL ARTERY THAT WAS OCCLUDING FLOW DISTALLY. IT WAS FURTHER REPORTED THAT MOST OF THE FRAGMENTS WERE SNARED, BUT A COVERED STENT WAS NEEDED TO SECURE A REMAINING PIECE THAT WAS NOT ABLE TO BE RETRIEVED. REPORTEDLY, FLOW WAS RESTORED, AND PATIENT WAS DOING FINE.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 17805553 ↗
• MalfunctionApr 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LEFT SUPERFICIAL FEMORAL ARTERY STENT PLACEMENT PROCEDURE, DURING REMOVAL OF THE DELIVERY SYSTEM, THE DISTAL INCH AND A HALF OF THE DELIVERY SYSTEM WAS ALLEGEDLY FOUND TO BE MISSING. IT WAS FURTHER REPORTED THAT THE SEGMENT THAT BROKE OFF WAS ON THE WIRE WITHIN THE SUPERFICIAL FEMORAL ARTERY AND THEREFORE THE HEALTH CARE PROVIDER SNARED THE TIP WITHIN THE INTRODUCER SHEATH. REPORTEDLY, THE TIP AND THE INTRODUCER SHEATH WERE THEN REMOVED AS A SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16750334 ↗
• InjuryAug 1, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DETACHED. REPORTEDLY, THE PIECE REMAINED IN THE PATIENT. THE CURRENT PATIENT STATUS WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 15138169 ↗
• MalfunctionFeb 15, 2022Fracture; Premature Activation; Fracture; Premature Activation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT SUPERFICIAL ARTERY (SFA) PROCEDURE THROUGH THE LEFT COMMON FEMORAL ACCESS, THE STENT STARTED TO ALLEGEDLY PREMATURELY DEPLOY WHILE ADVANCING UP AND OVER THE BIFURCATION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13533169 ↗
• MalfunctionJul 14, 2020Premature Activation; Self-Activation or Keying; Premature Activation; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 5F050803CS VASCULAR STENT ALLEGEDLY PREMATURELY DEPLOYED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10270989 ↗
• MalfunctionMar 9, 2018Positioning Failure; Entrapment of Device; Fracture; Kinked; Difficult to Remove; Misfire; Positioning Failure; Entrapment of Device; Fracture; Kinked; Difficult to Remove; Misfire

  IT WAS REPORTED THAT DURING TREATMENT OF A HEAVILY CALCIFIED POPLITEAL OCCLUSION VIA A CONTRALATERAL APPROACH, THE STENT ALLEGEDLY WOULD NOT DEPLOY. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER REMOVED THE GLIDEWIRE AND RE-FLUSHED THE DEVICE THROUGH THE LUMEN WITH CONTRAST AND SALINE WHILE INSIDE THE PATIENT. A SECOND ATTEMPT TO DEPLOY THE STENT WAS MADE, BUT RESISTANCE WAS FELT AND A POP NOISE WAS HEARD, POSSIBLE RELATED TO AN ALLEGED CORE WIRE FRACTURE. THE DELIVERY SYSTEM WAS REMOVED AND UPON REMOVAL THE STENT AND THE GLIDEWIRE ALLEGEDLY BECAME STUCK. REPORTEDLY, THE DEVICE AND THE GLIDEWIRE WERE REMOVED AS ONE UNIT. ACCESS WAS NOT LOST. THE DELIVERY SYSTEM WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7328859 ↗