Halyard 35116Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651351163), received between Oct 23, 2019 and Oct 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

• MalfunctionOct 23, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED IN THE JOURNAL ARTICLE "CUFF LEAKAGE CAUSED BY AUTOMATIC CUFF PRESSURE MONITOR AND WATER CONDENSATION IN THE INFLATION TUBE OF MICROCUFF ENDOTRACHEAL TUBE" THAT THERE WAS AN OCCURRENCE OF VENTILATION FAILURE ON A PATIENT TWO DAYS AFTER PATIENT ADMISSION. THE PATIENT HAD BEEN ADMITTED IN THE INTENSIVE CARE UNIT AND INTUBATED WITH 5.5 MM ID MICROCUFF ENDOTRACHEAL TUBE. INTRACUFF PRESSURE WAS SET AT 15 CMH2O AND MONITORED BY A CONTINUOUS AUTOMATIC CUFF PRESSURE MONITOR. THE FAILURE WAS FOUND TO BE CAUSED BY WATER CONDENSATION IN THE INFLATION TUBE. WHEN THE INTRACUFF PRESSURE WAS INCREASED TO FROM 15 TO 25CM H2O, WATER IN THE INFLATION TUBE MOVED TO THE CUFF AND THE ISSUE RESOLVED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9224575 ↗