Bivona XU18CS40NGE985NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517143171), received between May 1, 2018 and May 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 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.

• MalfunctionMay 1, 2018Deformation Due to Compressive Stress; Material Protrusion/Extrusion; Deformation Due to Compressive Stress; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE DISTAL END OF A PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE BULGED, AND WIRE CAME OUT OF THE TUBE. THE PRODUCT FAULT WAS DISCOVERED UPON REMOVAL OF THE TRACHEOSTOMY TUBE. THE TUBE CUT AND LACERATED THE PATIENT'S STOMA. THE PATIENT'S MOTHER STOPPED THE BLEEDING WITH GAUZE, AND SUCTIONED TO MAINTAIN THE AIRWAY. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Blood Loss; Laceration(s)

  MAUDE report 7477496 ↗

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.