Bivona 75FHXL60Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15021312015676), received between Dec 30, 2024 and Dec 30, 2024 — classified as 1 malfunction.

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

• MalfunctionDec 30, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXISTING TRACHEOSTOMY TUBE THAT WAS REQUIRING VERY HIGH CUFF PRESSURES TO SEAL. THE SAME TUBE WAS OBTAINED TO REPLACE THE TRACHEOSTOMY TUBE. WHEN THE PILOT BALLOON WAS INFLATED TO CHECK THE FUNCTION, IT WAS NOTED THAT THE BALLOON DID NOT INFLATE EQUALLY, ONE SIDE WAS SIGNIFICANTLY MORE FILLED WITH AIR THAN THE OTHER. DECISION NOT TO PLACE THIS TUBE IN THE PATIENT. THE ORIGINAL INTENDED PROCEDURE WAS TRACHEOSTOMY TUBE CHANGE. THE TRACHEOSTOMY IN THE PATIENT SEEMS TO REQUIRE VERY HIGH PRESSURES TO SEAL. IT IS THE SAME SIZE AND BRAND OF TRACH, BUT WE DO NOT HAVE ITS ORIGINAL LOT NUMBER OR INFORMATION. THE DEFECTIVE ITEM WAS NEVER PLACED IN THE PATIENT. THE EVENT OCCURRED AT THE HOSPITAL IN THE PATIENT'S ROOM. THE OUTCOME OF THE EVENT WAS THAT THE PATIENT HAD AN EXISTING PROBLEMATIC CUFF ON THEIR TRACH (REQUIRED HIGH PRESSURES) THAT WAS REPOSITIONED AND LEFT IN AT THE TIME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036250 ↗

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