Bivona CM3004NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517019902), received between Mar 1, 2017 and Mar 1, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Air Leak” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2017Air Leak; Inadequacy of Device Shape and/or Size; Infusion or Flow Problem; Air Leak; Inadequacy of Device Shape and/or Size; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING PATIENT USE OF THE BIVONA® CUSTOM 7.0MM FOME-CUF® STANDARD TRACHEOSTOMY TUBE, THE TRACHEOSTOMY TUBE WAS LEAKING AIR AROUND THE BOTTOM CUFF. THE REPORTED TRACHEOSTOMY TUBE HAD TWO DEVICE CUFFS, THE TOP CUFF WAS LOCATED AT THE STOMA AND THE BOTTOM CUFF WAS LOCATED AT THE DISTAL END OF THE SHAFT. ACCORDING TO THE REPORT, THE DEVICE WAS PROCESSED ON (B)(6) AND PLACED INTO THE PATIENT'S TRACHEA ON (B)(6). IT WAS REPORTED THAT DURING PLACEMENT THE DEVICE INSERTED INTO THE PATIENT'S STOMA EASIER THAN NORMAL AND WITH LESS RESISTANCE. IT WAS REPORTED THAT THE CUFF OF THE DEVICE WAS TOO SMALL. AFTER THREE DAYS PATIENT USE, THREE OF THE PATIENT'S NURSES DETERMINED THAT THE TRACHEOSTOMY TUBE WAS NOT MAINTAINING A PROPER SEAL IN ALL BODILY POSITIONS. ADDITIONALLY, THE NURSES NOTED A VENTILATION LEAK COMING OUT PATIENT'S STOMA. ON (B)(6), THE TRACHEOSTOMY TUBE WAS REPLACED WITH THE PATIENT PREVIOUS DEVICE. THE PATIENT EXPERIENCED LETHARGY AND THEIR LUNGS BECAME ATELECTASIS DUE TO THE REPORTED EVENT. IT WAS REPORTED THAT THE EVENT WAS RESOLVED AFTER THE TRACHEOSTOMY TUBE CHANGE. NO PERMANENT ADVERSE EFFECT TO PATIENT WAS REPORTED.

  Patient problems: Hypoventilation; Lethargy

  MAUDE report 6367891 ↗

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.