Bivona ST14EN80NSC324NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688787255), received between Oct 28, 2021 and Oct 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 other recall cover devices cleared under the same FDA submission (K923878); they may or may not involve this specific model.

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

• MalfunctionOct 28, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT BECOMES SORE IN THE THROAT DUE TO CUFF NOT BEING CENTERED. LEAKAGE THROUGH THE MOUTH IS EXPERIENCED AS WELL BECAUSE OF THIS ISSUE AFTER THE CUFF IS FILLED WITH STERILE WATER. BEFORE INSERTING THE CUFF, THE CUFF IS ALWAYS LEAK TESTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12716114 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.