Bivona ZT23BN60NSB029NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517333473), received between Jul 8, 2024 and Sep 9, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionSep 9, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT TRACH TUBE HAD A LEAK IN THE CUFF. THE PATIENT NEEDED IMMEDIATE SUCTION OF THE AIRWAY AS WATER WAS LEAKING INTO THE TRACHEA. TO RESOLVE THE ISSUE, THE TRACH WAS CHANGED. THERE WAS PATIENT INVOLVEMENT AND THERE WAS PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171434 ↗
• MalfunctionSep 9, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THEY ONLY NOTICED IT WHEN THE CUFF WAS INFLATED THAT THE PATIENT IMMEDIATELY BEGAN COUGHING. THEY CHANGED THE TRACH AND CHECKED THE CUFF, DISCOVERING IT HAD A HOLE IN IT. THE PATIENT NEEDED IMMEDIATE SUCTION OF THE AIRWAY AS WATER WAS LEAKING INTO THE TRACHEA. TO RESOLVE THE ISSUE, THE TRACH WAS CHANGED. THERE WAS PATIENT INVOLVEMENT AND THERE WAS PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171406 ↗
• MalfunctionJul 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHILE CLEANING THE INSIDE OF THE CUFF THERE APPEARED TO BE GROWING MOLD. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697402 ↗

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.