LifeStent® Vascular & Biliary Stent System EX050403CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049519007861), received between Feb 26, 2016 and Nov 6, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2020Failure to Advance; Positioning Problem; Failure to Advance; Positioning Problem

  IT WAS REPORTED THAT DURING TREATMENT IN THE LEFT ILIAC ARTERY, THE STENT ALLEGEDLY FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10799327 ↗
• MalfunctionSep 4, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN ALLEGED HAIR WAS IDENTIFIED IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7842998 ↗
• InjuryFeb 26, 2016Break; Difficult to Remove; Material Deformation; Break; Difficult to Remove; Sticking; Material Deformation

  IT WAS REPORTED THAT A STENT WAS SUCCESSFULLY DEPLOYED TO TREAT A FOCAL 90% STENOSIS IN THE DISTAL SFA/PROXIMAL POPLITEAL. DURING THE ATTEMPT TO REMOVE THE DELIVERY SYSTEM THE TIP OF THE DELIVERY SYSTEM GET CAUGHT ON THE STENOSIS. IN ORDER TO REMOVE THE DELIVERY SYSTEM THE USER PULLED HARDER BUT THE ARTERY MOVED AND THE USER WAS CONCERNED ABOUT TEARING THE VESSEL. THEREFORE, A SECOND WIRE WAS ADVANCED AND AN ANGIOPLASTY BALLOON WAS INFLATED AT THE STENT WAIST TO CREATE SPACE. FURTHERMORE, THE HAND PIECE OF THE DELIVERY SYSTEM WAS REMOVED TO DISENGAGE THE DELIVERY SYSTEM. ULTIMATELY, A LONG 7 FR SHEATH WAS ADVANCED INTO THE CEPHALAD PORTION OF THE STENT TO PROVIDE COUNTER PRESSURE AS THE DELIVERY SYSTEM WAS PULLED OUT. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ADDITIONAL ANGIOPLASTY BALLOON AND A COVERED STENT TO TREAT THE REMAINING STENOSIS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5462989 ↗