Halyard 44566Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651445664), received between Jan 29, 2020 and Jan 29, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Malposition of Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJan 29, 2020Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED 04-FEB-2020 VIA MEDWATCH/ FDA USER FACILITY REPORT # MW (B)(4) NOTED: ELDERLY FEMALE PATIENT WITH UNRESECTABLE ESOPHAGEAL CANCER AND DYSPHAGIA UNDERWENT ELECTIVE FEEDING JEJUNOSTOMY TUBE REPLACEMENT. AFTERWARDS, SHE DEVELOPED SBO INITIALLY THOUGHT TO BE RELATED TO A TWIST IN THE SMALL BOWEL-THIS WAS SURGICALLY CORRECTED. AFTER THAT, HER SBO FAILED TO RESOLVE, AND REPEAT IMAGING SHOWED THAT THE 3ML BALLOON OF THE J-TUBE TO BE THE POINT OF OBSTRUCTION. THE BALLOON WAS DEFLATED, BUT BY THAT TIME SHE HAD ALREADY ASPIRATED, DEVELOPED PNEUMONIA, THEN SEPSIS AND DEATH. DOCTOR'S RECOMMENDATION IS TO FIND A DIFFERENT J-TUBE THAT DOES NOT HAVE A BALLOON. CURRENTLY THE MANUFACTURER DOES NOT OFFER THE FEEDING J-TUBE WITHOUT THE BALLOON. IT WAS THOUGHT THAT THE BALLOON WAS NOT LARGE ENOUGH TO CAUSE A SMALL BOWL OBSTRUCTION, BUT THIS IS A SENTINEL CASE THAT PROVES THE BALLOON IS LARGE ENOUGH TO CAUSE OBSTRUCTION.

  Patient problems: Aspiration/Inhalation; Death; No Code Available; Obstruction/Occlusion; Pneumonia; Sepsis

  MAUDE report 9641390 ↗