LIFESTENT® 5F060403CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741120152), received between Nov 1, 2021 and May 18, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionMay 18, 2026Break; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT VASCULAR STENT. DURING THE PROCEDURE, THE STENT IS INSERTED, AND THE DEPLOYMENT SYSTEM IS REMOVED. THE LIFESTREAM STENT CATHETER BROKE AFTER DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197775 ↗
• MalfunctionApr 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A PATIENT UNDERWENT A LIFESTENT PROCEDURE FOR UNKNOWN MEDICAL CONDITION, IT WAS FURTHER REPORTED THAT THE DEPLOYED STENT WAS AN EXPIRED STENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924643 ↗
• MalfunctionApr 25, 2024Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY UNABLE TO BE DEPLOYED. IT WAS FURTHER REPORTED THAT AN ATTEMPT WAS MADE TO REMOVE THE STENT, BUT IT WAS UNSUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181474 ↗
• InjuryNov 17, 2023Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY VIA COMMON FEMORAL ACCESS, THE GUIDEWIRE ALLEGEDLY FELT RESISTANCE WHEN ADVANCED INSIDE THE DELIVERY SYSTEM AND THEN THE STENT WAS DELIVERED AND REMOVED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THERE WAS AN UNKNOWN OBJECT WAS FOUND IN THE ARTERY AND WHEN THE DELIVERY SYSTEM WAS VERIFIED IT WAS ALLEGEDLY FOUND THAT THE TIP OF THE DELIVERY SYSTEM WAS MISSING. REPORTEDLY, WHILE REMOVING THE TIP USING A SNARE, A THROMBUS WAS RELEASED AND TPA WAS ADMINISTERED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18157517 ↗
• MalfunctionNov 13, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808082 ↗
• MalfunctionNov 3, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN STENT PLACEMENT PROCEDURE THROUGH THE RIGHT GROIN THROUGH THE RIGHT LEG IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE TIP OF THE STENT SYSTEM ALLEGEDLY CAME OFF. THE DEVICE WAS REMOVED USING A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745568 ↗
• MalfunctionNov 1, 2021Break; Activation, Positioning or Separation Problem

  THE PATIENT HAD A SELF-EXPANDING STENT PLACED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AT THAT TIME, PATIENT HAD 100% STENOSIS OF THE MID-RIGHT SUPERFICIAL FEMORAL ARTERY. PATIENT WAS TAKEN BACK TO THE CATHETERIZATION LAB BECAUSE THERE WAS 100% STENOSIS OF THE MID TO DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY. A 5F SHEATH AND A GLIDEWIRE ADVANTAGE® GUIDEWIRE PLACED IN THE DISTAL RIGHT PERONEAL ARTERY WERE USED. BALLOON ANGIOPLASTY WAS PERFORMED IN THE MID TO DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY, THE POPLITEAL ARTERY, AND THEN THE PERONEAL ARTERY. ANGIOGRAPHY DEMONSTRATED A DISSECTION FLAP JUST DISTAL TO THE PREVIOUSLY PLACED STENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND THIS WAS COVERED WITH A LIFESTENT® 5F SELF-EXPANDING VASCULAR STENT. IT WAS IMMEDIATELY APPARENT AFTER DEPLOYMENT OF THE STENT THAT THE DISTAL PORTION OF THE STENT DELIVERY SYSTEM WAS RETAINED WITHIN THE VESSEL DUE TO MALFUNCTION OF THE STENT DELIVERY SYSTEM. A 3.2 MM GOOSE NECK SNARE DELIVERY SYSTEM WAS USED TO RETRIEVE THE RETAINED FOREIGN BODY IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND RETRACTED THROUGH THE SHEATH, NOTHING WAS LEFT BEHIND. THE RETAINED (BROKEN OFF) PORTION IS APPROXIMATELY 8-9 INCHES LONG.

  Patient problems: Insufficient Information

  MAUDE report 12727238 ↗