Bivona CMZ3050NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517114270), received between May 2, 2019 and May 2, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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.

• InjuryMay 2, 2019Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  INFORMATION WAS RECEIVED THAT THREE SMITHS MEDICAL BIVONA CUSTOM TTS TRACHEOSTOMY TUBES WERE MADE FOR ONE PATIENT. THE REPORTER STATED ALL THREE TUBES HAVE GIVEN THE PATIENT DISCOMFORT AND PAIN WHILE WEARING THEM AND THAT THEY "CAUSE IRRITATION INSIDE THE TRACHEA. AN OLD TRACH HAS TO BE PUT IN WHILE THE TRACHEA HEALS. WHEN THE TRACHEA HEALS, THEY TRY ANOTHER NEW TRACH AND THE SAME ISSUE ARISES. THIS HAPPENED THREE TIMES. THE END OF THE TUBE HAS A BUMP THAT IS THOUGHT TO BE CAUSING THE IRRITATION". IT WAS ALSO NOTED THE PATIENT DEVELOPED A TRACHEAL ERYTHEMA, BUT WAS ABLE TO RECOVER ONCE THE TUBES WERE CHANGED OUT TO A DIFFERENT CUSTOM SMITHS MEDICAL TRACHEOSTOMY TUBE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort; Erythema; Pain; Skin Irritation

  MAUDE report 8574517 ↗
• InjuryMay 2, 2019Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  INFORMATION WAS RECEIVED THAT THREE SMITHS MEDICAL BIVONA CUSTOM TTS TRACHEOSTOMY TUBES WERE MADE FOR ONE PATIENT. THE REPORTER STATED ALL THREE TUBES HAVE GIVEN THE PATIENT DISCOMFORT AND PAIN WHILE WEARING THEM AND THAT THEY "CAUSE IRRITATION INSIDE THE TRACHEA. AN OLD TRACH HAS TO BE PUT IN WHILE THE TRACHEA HEALS. WHEN THE TRACHEA HEALS, THEY TRY ANOTHER NEW TRACH AND THE SAME ISSUE ARISES. THIS HAPPENED THREE TIMES. THE END OF THE TUBE HAS A BUMP THAT IS THOUGHT TO BE CAUSING THE IRRITATION". IT WAS ALSO NOTED THE PATIENT DEVELOPED A TRACHEAL ERYTHEMA, BUT WAS ABLE TO RECOVER ONCE THE TUBES WERE CHANGED OUT TO A DIFFERENT CUSTOM SMITHS MEDICAL TRACHEOSTOMY TUBE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort; Erythema; Pain; Skin Irritation

  MAUDE report 8574516 ↗
• InjuryMay 2, 2019Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  INFORMATION WAS RECEIVED THAT THREE SMITHS MEDICAL BIVONA CUSTOM TTS TRACHEOSTOMY TUBES WERE MADE FOR ONE PATIENT. THE REPORTER STATED ALL THREE TUBES HAVE GIVEN THE PATIENT DISCOMFORT AND PAIN WHILE WEARING THEM AND THAT THEY "CAUSE IRRITATION INSIDE THE TRACHEA. AN OLD TRACH HAS TO BE PUT IN WHILE THE TRACHEA HEALS. WHEN THE TRACHEA HEALS, THEY TRY ANOTHER NEW TRACH AND THE SAME ISSUE ARISES. THIS HAPPENED THREE TIMES. THE END OF THE TUBE HAS A BUMP THAT IS THOUGHT TO BE CAUSING THE IRRITATION". IT WAS ALSO NOTED THE PATIENT DEVELOPED A TRACHEAL ERYTHEMA, BUT WAS ABLE TO RECOVER ONCE THE TUBES WERE CHANGED OUT TO A DIFFERENT CUSTOM SMITHS MEDICAL TRACHEOSTOMY TUBE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort; Erythema; Pain; Skin Irritation

  MAUDE report 8574515 ↗

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.