Bivona CMZ3289NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517148688), received between May 22, 2019 and Oct 13, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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.

• MalfunctionOct 13, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CUSTOM-MADE TRACHEOSTOMY TUBE IS NOT ACCORDING TO SPECIFICATIONS. THE FIXED FLANGE IS NOT FIXED AND A RING WAS ADDED TOO CLOSE TO THE PROXIMAL FOME-CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598755 ↗
• InjuryJul 30, 2019Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED THAT WHEN DISCONNECTING A SMITHS MEDICAL (B)(4) CUSTOM TUBE FROM THE ISO CONNECTOR, THE ISO CONNECTOR DETACHED FROM THE REST OF THE CANNULA LEAVING NO CONNECTION FOR THE VENTILATOR. A REPLACEMENT CANNULA HAD TO BE INSERTED PROMPTLY. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8843385 ↗
• InjuryMay 22, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT TRACHEOSTOMY TUBE WAS DISCONNECTED FROM THE ISO CONNECTOR, THE ISO CONNECTOR DETACHED FROM THE REST OF THE CANNULA LEAVING NO CONNECTION TO THE VENTILATOR. AN UNPLANNED REPLACEMENT CANNULA HAD TO BE INSERTED PROMPTLY. IN ADDITION, A RESUSCITATOR WAS ALSO USED ON THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634220 ↗

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.