Bivona CMZ3236NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517143980), received between Mar 25, 2021 and Mar 25, 2021 — 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 (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.

• MalfunctionMar 25, 2021Inflation Problem; Obstruction of Flow; Inflation Problem; Obstruction of Flow

  DURING A ROUTINE TRACHEOSTOMY CHANGE, PARENTS WERE UNABLE TO DEFLATE THE FOME CUF TO REMOVE THE TUBE IN SITU. PROBLEM SOLVING WAS ATTEMPTED BUT NOT SUCCESSFUL. PARENTS TOOK KID TO ED WHERE ENT WAS ABLE TO REMOVE THE TUBE WITH STEADY PRESSURE. UPON CLOSER INSPECTION OF THE FAULTY TUBE, IT APPEARED THAT THERE WAS A COMMUNICATION BETWEEN THE EMBEDDED CUFF INFLATION LINE AND THE INSIDE OF THE DISTAL SHAFT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566738 ↗

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.