Bivona AT20FS35NGA035NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517231922), received between Jul 20, 2020 and Sep 21, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST THE CUFF WAS NOT INFLATING FULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461886 ↗
• InjuryJul 20, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL BIVONA CUSTOMIZED TRACHEOSTOMY TUBE, THE CUFF WOULD NOT DEFLATE. IT WAS REPORTED THAT ALL THE WATER WAS REMOVED FROM THE CUFF AND PILOT BALLOON AND WAS DIFFICULT TO REMOVE. THE TRACH TUBE WAS REMOVED, AND THE CUFF WAS STILL INFLATED. ANOTHER TRACH TUBE WAS PLACED WITH NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296280 ↗

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.