Bivona FU21KN40NGE079NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517287851), received between Jan 21, 2022 and Jan 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (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 21, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE MOTHER CALLED THIS WRITER AND STATED THAT WHEN THE TRACH CHANGE WAS DONE ON (B)(6) 2022, SHE NOTED BLOOD ON THE END OF THE TRACH. WHEN SHE CLEANED AND TOUCHED THE END, SHE NOTED IT WAS SHARP, AND THE MATERIAL "WHITE LINE" APPEARED TO BE COMING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314617 ↗

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.