Halyard 35164Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651351644), received between Jun 29, 2018 and Jun 29, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionJun 29, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PILOT LINE ON THE MICROCUFF CAME AWAY FROM THE TUBE DURING EXTUBATION. IT REMAINED IN THE MOUTH WHEN THE TUBE WAS REMOVED. THE PILOT LINE WAS REMOVED INTACT, BUT A DIRECT LARYNGOSCOPY WAS PERFORMED TO ENSURE THERE WAS NOTHING LEFT IN THE AIRWAY. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652948 ↗