Bivona ZA24FN85ZSZ237NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517390766), received between Aug 13, 2024 and Aug 13, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionAug 13, 2024Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WOULD NOT HOLD AIR IN THE CUFF. THE PATIENT WAS AWAKENED BY A LEAK WHEN THE CUFF WAS LOW AND WAS ABLE TO TALK. THEY FILLED THE CUFF AND 6ML OF AIR LEAKED OUT IN LESS THAN 20 MINUTES. THERE WAS MEDICAL INTERVENTION REQUIRED, THE TRACH NEEDED TO BE CHANGED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973570 ↗

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.