Bivona ZZ19CN80NSC155NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517186932), received between Dec 23, 2019 and Mar 9, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A LEAKING CUFF. A HOLE WAS NOTICED IN THE CUFF. LEAKING OF FLUID FROM CUFF NECESSITATED ASPIRATION TO REMOVE IRRITATION BY THE CUFF FLUID. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Low Oxygen Saturation; Skin Inflammation/ Irritation

  MAUDE report 13714868 ↗
• InjuryMar 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A LEAKING CUFF. A HOLE WAS NOTICED IN THE CUFF. LEAKING OF FLUID FROM CUFF NECESSITATED ASPIRATION TO REMOVE IRRITATION BY THE CUFF FLUID. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Low Oxygen Saturation; Skin Inflammation/ Irritation

  MAUDE report 13711664 ↗
• MalfunctionDec 23, 2019Crack; Fungus in Device Environment; Material Split, Cut or Torn; Crack; Fungus in Device Environment; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT THE FLANGE OF A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE, A CRACK WAS FOUND. MOLD WAS REPORTED TO BE OBSERVED IN THE TRACH. THE PLASTIC RING WAS TAKEN OUT AND CLEANED. HOWEVER, IT WAS REPORTED THAT AFTER THE THIRD TIME CLEANING THE RING, IT WAS OBSERVED TO BECOME DETACHED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9514300 ↗
• MalfunctionDec 23, 2019Crack; Fungus in Device Environment; Material Split, Cut or Torn; Crack; Fungus in Device Environment; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT THE FLANGE OF A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE, A CRACK WAS FOUND. MOLD WAS REPORTED TO BE OBSERVED IN THE TRACH. THE PLASTIC RING WAS TAKEN OUT AND CLEANED. HOWEVER, IT WAS REPORTED THAT AFTER THE THIRD TIME CLEANING THE RING, IT WAS OBSERVED TO BECOME DETACHED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9514298 ↗

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.