Bivona XA23LS60ZSC081NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517369793), received between May 27, 2026 and Sep 28, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Inflation Problem

  It was reported that the tracheostomy tube experienced unintended inflation of the inner cuff when air was introduced into the outer cuff, which prevented the patient from speaking. The issue was identified after the device had been placed in the patient's airway. There was patient involvement associated with this event; however, no patient harm or adverse effects were reported, as the patient remained under continuous monitoring.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916124 ↗
• MalfunctionMay 27, 2026Inflation Problem

  IT WAS REPORTED THAT TWO ADULT EXPANDABLE CIRCUITS EXHIBITED A DEFECT WHERE THE INNER CUFF OF THE TRACHEOSTOMY TUBE INFLATED SIMULTANEOUSLY WHEN AIR WAS ADDED TO THE OUTER CUFF. THIS ISSUE WAS IDENTIFIED AFTER THE DEVICES WERE PLACED IN THE PATIENT¿S AIRWAY. NO ADVERSE EFFECTS OCCURRED, AS THE PATIENT WAS CONTINUOUSLY MONITORED. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304187 ↗

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.