Bivona FT19DN70NSC848NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517189957), received between Jan 25, 2023 and Jan 27, 2023 — classified as 1 injury, 1 malfunction.

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

• InjuryJan 27, 2023Inflation Problem; Defective Device; Inflation Problem; Defective Device

  IT WAS REPORTED THAT THE CUSTOM TRACH THE CUSTOMER ORDERED WAS SUPPOSED TO BE 70MM AND THEY RECEIVED 80MM. THE CUFF WAS ALSO NOT INFLATING. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT DURING USE ISSUE OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16257902 ↗
• MalfunctionJan 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUSTOMER REPORTED THAT THEY SENT THIS BACK IN JULY FOR CUSTOM TRACH. THE CHILD WAS IN HOSPITAL AT THE TIME OF THE ISSUE. THE LENGTH THAT THEY RECEIVE WAS 70MM. AND THE ORDER WAS 80MM. TWO (2) OF THE TRACH'S, THE BALLOON WOULD NOT INFLATE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT DURING USE ISSUE OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16243437 ↗

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.