Bivona ZT20FN60NSB061NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517232387), received between Aug 26, 2020 and Aug 26, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryAug 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CUSTOM TRACHEOSTOMY TUBE WAS PLACED AND A DAY AFTER, THE PATIENT COMPLAINED OF SEVERAL ITCHING SPOTS NEAR THE STOMA. THE PARENTS NOTED THAT THE AREA AROUND THE STOMA WAS RED. AFTER ONE MORE DAY, THE CHILD WAS UNABLE TO HANDLE THE PAIN ANY MORE AND THE TRACH HAD TO BE CHANGED. PARENTS NOTED THAT THERE WAS BLEEDING AROUND THE STOMA. THE TRACH WAS REPLACED WITH A STOCK TRACH AND WITHIN 20 MINUTES, THE ITCHING AND DISCOMFORT SUBSIDED AND THE PATIENT CONTINUED TO HEAL WITH NO FURTHER COMPLICATIONS.

  Patient problems: Itching Sensation

  MAUDE report 10455093 ↗

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.