Bivona SU22CN40NGF005SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517300352), received between Aug 30, 2022 and Aug 30, 2022 — classified as 2 malfunctions.

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

• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT HAS A CUSTOM TRACH WHERE THE FLANGE ON THE SIDE HAS BROKEN TWICE IN A MONTH. THE ISSUE HAPPENED ON SEPARATE OCCASIONS CAUSING THE TRACH TO DISLODGE. IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED AT THIS TIME. NO PATIENT INJURY OR ADVERSE AFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321715 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT HAS A CUSTOM TRACH WHERE THE FLANGE ON THE SIDE HAS BROKEN TWICE IN A MONTH. THE ISSUE HAPPENED ON SEPARATE OCCASIONS CAUSING THE TRACH TO DISLODGE. IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED AT THIS TIME. NO PATIENT INJURY OR ADVERSE AFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321651 ↗

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.