Bivona 60HA50Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15021312013733), received between Feb 3, 2025 and Feb 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081440); 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 16, 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.

• MalfunctionFeb 3, 2025Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CANNULA WAS REMOVED FROM A CHILD FOLLOWING PARTIAL RUPTURE NEAR THE TIP. THE CANNULA WAS PUT IN PLACE OVER 1 MONTH AGO, THE PATIENT'S MOTHER CLEANED AND STERILIZED IT WITH BOILING WATER ONCE AND WHEN SHE PUT IT BACK, SHE NOTICED THAT IT WAS "SPLIT". THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293723 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081440. One submission often covers many models, so check the product and lot details in each record.

• Z-2485-2020 · May 26, 2020 · Terminated
  Pediatric Adjustable Flange Tracheostomy Tube Cuffless