Halyard 35217Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651352177), received between Apr 29, 2017 and Apr 29, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionApr 29, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER THE PATIENT WAS INTUBATED WITH AN 8.5 MICROCUFF ENDOTRACHEAL TUBE (ETT), THE MICROCUFF BEGAN TO LEAK AND THE PATIENT EXPERIENCED VENTILATOR LOSS. THE PATIENT WAS RE-INTUBATED WITH AN 8.0 MICROCUFF ETT, USING A BOUJIE AND STYLET. DURING THE REMOVAL OF THE 8.5 MICROCUFF, THE PHYSICIAN ALLEGED HAVING TO PEEL AWAY SOME CUFF MATERIAL FROM THE PHARNYX OF THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS DIFFICULTY WITH THE INTUBATION, AND THE CLINICIAN THEN USED THE STYLET WITH A GLIDESCOPE. WHEN THE CUFF PRESSURE WAS INITIALLY CHECKED IT READ 50 CMH2O, THE CUFF PRESSURE THEN WAS REDUCED TO 30 CMH2O. NO BITE BLOCK OR ORAL AIRWAY WAS USED. THE PATIENT VOMITED DURING POST INTUBATION ATTEMPTS. ADDITIONAL INFORMATION FROM THE ANESTHESIOLOGIST WAS RECEIVED. THE MAJORITY OF THE 8.5 MICROCUFF WAS OFF THE TUBE IN THE PHARYNX DURING THE EXCHANGE, ALMOST AS IF IT HAD PEELED OFF THE TUBE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6532249 ↗