Bivona XT23GS60NGC212NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517393491), received between Nov 11, 2024 and Nov 11, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• InjuryNov 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TRACH CARE, AN OVERFILL OF THE TRAIN BALLOON WAS NOTED AND WHILE EXTRACTING WATER FROM THE PILOT BALLOON, IT HAD MORE RESISTANCE THAN NORMAL AND WAS SLOW TO EXTRACT. THE BALLOON WOULD BE COMPLETELY COMPRESSED AND REFILL AFTER WAITING. FILLING WATER IN PILOT BALLOON HAD RESISTANCE AND PILOT BALLOON WAS NOTED TO BE LOPSIDED DURING FILL AND TRACH ITSELF WAS LOPSIDED. BOTH WERE MANIPULATED TO FORM SYMMETRICAL SHAPE. THERE WAS MEDICAL INTERVENTION REQUIRED, AND THE OUTCOME OF THE INJURY (BLEEDING FROM AIRWAY) WAS RESOLVED BY ON (B)(6) 2024. THE ISSUE WAS RESOLVED BY CHANGING OUT THE TRACH FOR VISIBLE TESTING. THERE WAS PATIENT INVOLVEMENT, WITH INJURY AND NO DEATH EVENT REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20651360 ↗

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.