Bivona FT19EN50NSF060NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517192186), received between Jul 18, 2022 and Nov 4, 2022 — classified as 2 malfunctions.

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

• MalfunctionNov 4, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT A BRAND NEW TRACH WAS TAKEN OUT OF THE BOX. PLACED ON PATIENT AND WHEN CAREGIVER WENT TO SECURE THE TRACH WITH TRACH TIES THE FLANGE BROKE. NO INJURY REPORTED AND NO MEDICAL INTERVENTION, THEY USED THEIR EMERGENCY TRACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734641 ↗
• MalfunctionJul 18, 2022Break

  IT WAS REPORTED THAT THE PATIENT BECAME DECANNULATED AS THE FLANGE OF THE TRACH BROKE AND IT BECAME UNSECURED. THERE WAS INJURY, NO HARM TO PATIENT OR ADVERSE AFFECTS. NO NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15046697 ↗

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.