Bivona HT23CS55NSA960NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517341683), received between Mar 21, 2024 and Mar 21, 2024 — classified as 1 malfunction.

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

• MalfunctionMar 21, 2024Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON ON THE TRACH KEEPS DEFLATING AND IS NOT HOLDING AIR. THE DISTRIBUTER HAD TO SEND A REPLACEMENT TRACH EMERGENTLY TO PROVIDE PROPER WORKING PRODUCT TO THEIR CUSTOMER. THEY NEED A TRACH THAT WILL STAY IN PLACE. NO PATIENT HARM/ADVERSE EVENT REPORTED. IN ADDITION TO THE ABOVE DOCUMENTATION, THE PATIENT'S MOTHER STATED THAT SHE ALWAYS INFLATES BEFORE PUTTING ANY PRODUCT INTO HER SON TO MAKE SURE THERE WAS NO DEFECT ON THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951096 ↗

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.