Bivona CMZ2050NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517113648), received between Aug 16, 2023 and Mar 28, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024Unclear Information; Unclear Information

  IT WAS REPORTED THAT THE DEVICE "TREND" WAS NOT HOLDING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991970 ↗
• MalfunctionAug 16, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PRE-TESTING THE CUSTOMER FOUND TWO CUSTOM TRACH TUBES (WITH THE SAME LOT NUMBER) THAT WERE OUTSIDE THE PRESCRIBED DIMENSIONS, MAKING THE UNUSABLE. THE ANGLE MEASURED 6 DEGREES VS 12.5. BOTH SETS WOULD HAVE CAUSED HARM TO USER BUT WERE CAUGHT BEFORE USE. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559919 ↗
• MalfunctionAug 16, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PRE-TESTING THE CUSTOMER FOUND TWO CUSTOM TRACH TUBES (WITH THE SAME LOT NUMBER) THAT WERE OUTSIDE THE PRESCRIBED DIMENSIONS, MAKING THEM UNUSABLE. THE ANGLE MEASURED 8 DEGREES VS 12.5. BOTH SETS WOULD HAVE CAUSED HARM TO USER BUT WERE CAUGHT BEFORE USE. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559837 ↗

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.