Bivona 67FHXL70Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05021312013767), received between Jun 30, 2022 and Jun 30, 2022 — classified as 1 malfunction.

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

• MalfunctionJun 30, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT A WIRE WAS PROTRUDING FROM TRACHEOSTOMY TUBE IN PLACE IN A PATIENT. THE WIRE WAS ABOUT 2.5 INCHES IN LENGTH. NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. WE HAVE REACHED OUT FOR MORE DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876225 ↗

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