Bivona ST24JN80FTZ093NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887709135007), received between Jan 22, 2026 and Jan 22, 2026 — 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.

• MalfunctionJan 22, 2026Leak/Splash

  IT WAS REPORTED THAT THE NURSING SERVICE NOTICED THAT WATER (10 ML), WHICH IS USED TO INFLATE THE CUFF, HAS LEAKED OUT OF THE CUFF. SUBSEQUENTLY, THE NURSING SERVICE TOOK A CLOSER LOOK AT THE CANNULA AND SAW THAT THERE IS A SMALL HOLE IN THE CUFF, AND THEREFORE IT IS LEAKING. FOR THE NURSING SERVICE, WAS DIFFICULT TO ASSESS WHETHER THE PATIENT HAS SUFFERED ANY HEALTH IMPAIRMENT AS A RESULT OF THIS INCIDENT, AS THE PATIENT¿S CURRENT CONDITION IS GENERALLY RATHER WORSE DUE TO INFECTIONS. THE ADVICE TO SEEK MEDICAL HELP WAS GIVEN TO THE NURSING SERVICE. THE USER OF THE DEVICE WHEN THE EVENT OCCURRED WAS A HEALTHCARE PROFESSIONAL. THE PLACE WHERE THE EVENT OCCURRED WAS AT THE PATIENT'S HOUSE. THE NURSING SERVICE HAS SWITCHED TO A BACKUP CANNULA AND PROVIDED VENTILATORY INSUFFICIENCY IN ALS. THE NURSING SERVICE STATED THAT IT IS DIFFICULT TO ASSESS, AS THE PATIENT IS CURRENTLY IN POOR HEALTH DUE TO INFECTIONS. THE CLIENT RECOMMENDED TO THE NURSING SERVICE TO SEEK MEDICAL ASSISTANCE IF THE PATIENT'S CONDITION SHOULD WORSEN. THE INCIDENT IS RESOLVED IN THE SENSE THAT A DIFFERENT CANNULA WAS PLACED FOR THE PATIENT. THEY ALSO FOUND A HOLE IN THE CUFF. THE PATIENT HAS A MULTI-RESISTANT GERM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152361 ↗

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.