Bivona FT19EN40NGF880NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517192858), received between Aug 27, 2021 and Feb 8, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2022Break; Break

  IT WAS REPORTED THAT NURSE NOTICED DURING DRESSING CARE ONE FLANGE OF THE TRACHEOSTOMY WAS COMPLETELY TORN. PATIENT WAS ASLEEP AND TRACHEOSTOMY TUBE DID NOT DISLODGE. TRACHEOSTOMY WAS IMMEDIATELY CHANGED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13485270 ↗
• InjuryAug 27, 2021Break; Break

  IT WAS REPORTED THAT DURING ROUNDS, THE RT FOUND THE PATIENT WITH TRACH DISLODGED. RT TRIED TO REINSERT AND FOUND THAT THE EYELET WAS TORN. A COUPLE DAYS LATER, THE SAME ISSUE WAS FOUND. A TRACH CHANGE WAS DONE EACH TIME TO RESOLVE THE ISSUE. THE CUSTOMER DOES NOT USE THE IFU RECOMMENDED TRACH TIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380596 ↗
• InjuryAug 27, 2021Break; Break

  IT WAS REPORTED THAT DURING ROUNDS, THE RT FOUND THE PATIENT WITH TRACH DISLODGED. RT TRIED TO REINSERT AND FOUND THAT THE EYELET WAS TORN. A COUPLE DAYS LATER, THE SAME ISSUE WAS FOUND. A TRACH CHANGE WAS DONE EACH TIME TO RESOLVE THE ISSUE. THE CUSTOMER DOES NOT USE THE IFU RECOMMENDED TRACH TIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380538 ↗

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.