LifeStent® Biliary Stent EX100801CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04049519000619), received between Nov 24, 2015 and May 17, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT, THE DEVICE ALLEGEDLY HAD STENT ELONGATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831639 ↗
• MalfunctionJul 21, 2016Labelling, Instructions for Use or Training Problem; Incorrect Measurement; Device Operates Differently Than Expected; Labelling, Instructions for Use or Training Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT, THE STENT LENGTH WAS MEASURED TO BE 120 MM INSTEAD OF 80 MM. THE STENT LENGTH IN VIVO WAS ESTIMATED BY MEANS OF A NON-INFLATED 80 MM BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 5811698 ↗
• MalfunctionApr 4, 2016Device Slipped; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE FOR TREATMENT OF A RECURRING LESION IN THE CEPHALIC VEIN, THE WHEEL OF THE DEPLOYMENT MECHANISM STOPPED CLICKING AFTER TWO TURNS AND THE TIP OF THE VASCULAR STENT WAS SHOT OUT. THE PLACEMENT OF THE STENT WAS CONTINUED WITHOUT ISSUE AND THE STENT COULD BE IMPLANTED SUCCESSFULLY AFTER THE INITIAL MALFUNCTION. NO OTHER DEVICE HAD TO BE USED AND NO ADDITIONAL TREATMENT WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5545234 ↗
• MalfunctionFeb 10, 2016Break; Break; Positioning Failure

  IT WAS REPORTED THAT THE BILIARY STENT COULD NOT BE DEPLOYED IN THE CEPHALIC ARCH DURING THE STENT PLACEMENT PROCEDURE. THE ACCESS SITE WAS AN A/V FISTULA. THE STENT DELIVERY SYSTEM COULD BE RETRACTED WITHOUT DIFFICULTIES AND ANOTHER STENT OF THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 5427558 ↗
• MalfunctionNov 24, 2015Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE IN THE CEPHALIC ARCH, THE BILIARY STENT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING PARTIALLY RELEASED. THE DELIVERY SYSTEM AND THE GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 5245361 ↗