LifeStent® Biliary Stent EX100401CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049519000572), received between Feb 26, 2016 and Sep 18, 2017 — classified as 3 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.

• MalfunctionSep 18, 2017Migration or Expulsion of Device; Device Operates Differently Than Expected; Migration or Expulsion of Device; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER SUCCESSFULLY DEPLOYING THE STENT DURING AN INTRAOPERATIVE PROCEDURE, THE HEALTH CARE PROVIDER NOTICE DURING THE POST DILATION PROCESS THAT THE BILIARY STENT ALLEGEDLY MIGRATED DISTALLY AND ELONGATED IN THE RIGHT COMMON ILIAC VIA A CONTRALATERAL (LEFT) COMMON FEMORAL APPROACH. REPORTEDLY, THE STENT WAS LEFT IN PLACE AS IT WAS STILL COVERING THE TREATMENT AREA. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6874494 ↗
• MalfunctionSep 12, 2016Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN A PRE-DILATED RIGHT FEMORAL VEIN GRAFT ANASTOMOSIS VIA ACCESS THROUGH A RIGHT FEMORAL A/V GRAFT, THE BILIARY STENT COULD NOT BE DEPLOYED. ANOTHER DEVICE FROM THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5942957 ↗
• MalfunctionFeb 26, 2016Premature Activation; Difficult to Remove

  IT WAS REPORTED THAT THE STENT STARTED TO PREMATURELY DEPLOY DURING ADVANCING THE SYSTEM TO THE LESION SITE. THE SYSTEM WAS REMOVED FROM THE PATIENT WITH DIFFICULTY AS THE SYSTEM WAS DIFFICULT TO REMOVE OVER THE GUIDE WIRE. ANOTHER SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5462601 ↗