Bivona SU20HN35NGF965NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517238174), received between Dec 2, 2020 and Dec 3, 2020 — classified as 3 malfunctions.

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

• MalfunctionDec 3, 2020Break; Break

  IT WAS REPORTED THAT THE BIVONA TRACHEOSTOMY TUBE WAS BROKEN. THIS WAS OBSERVED WHEN THE DRESSING WAS BEING CHANGED ON THE RESPIRATOR DEPENDENT PATIENT. THE PATIENT HAD A HISTORY OF THE FOLLOWING: CHRONIC RESPIRATORY FAILURE, UNSPECIFIED WITH HYPOXIA OR HYPERCAPNIA, DYSPHAGIA (UNSPECIFIED) CONGENITAL MALFORMATION (UNSPECIFIED), CONGENITAL TRACHEO-ESOPHAGEAL FISTULA WITHOUT ATRESIA, AND ACUTE KIDNEY FAILURE (UNSPECIFIED). NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. THE EVENT WAS DESCRIBED AS RESOLVED. THE AFFECTED BIVONA TRACHEOSTOMY TUBE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10938252 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT THE BIVONA TRACHEOSTOMY TUBE WAS BROKEN. THIS WAS OBSERVED WHEN THE DRESSING WAS BEING CHANGED ON THE RESPIRATOR DEPENDENT PATIENT. THE PATIENT HAD A HISTORY OF THE FOLLOWING: CHRONIC RESPIRATORY FAILURE, UNSPECIFIED WITH HYPOXIA OR HYPERCAPNIA, DYSPHAGIA (UNSPECIFIED) CONGENITAL MALFORMATION (UNSPECIFIED), CONGENITAL TRACHEO-ESOPHAGEAL FISTULA WITHOUT ATRESIA, AND ACUTE KIDNEY FAILURE (UNSPECIFIED). NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. THE EVENT WAS DESCRIBED AS RESOLVED. THE AFFECTED BIVONA TRACHEOSTOMY TUBE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10935907 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT THE BIVONA TRACHEOSTOMY TUBE WAS BROKEN. THIS WAS OBSERVED WHEN THE DRESSING WAS BEING CHANGED ON THE RESPIRATOR DEPENDENT PATIENT. THE PATIENT HAD A HISTORY OF THE FOLLOWING: CHRONIC RESPIRATORY FAILURE, UNSPECIFIED WITH HYPOXIA OR HYPERCAPNIA, DYSPHAGIA (UNSPECIFIED) CONGENITAL MALFORMATION (UNSPECIFIED), CONGENITAL TRACHEO-ESOPHAGEAL FISTULA WITHOUT ATRESIA, AND ACUTE KIDNEY FAILURE (UNSPECIFIED). NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. THE EVENT WAS DESCRIBED AS RESOLVED. THE AFFECTED BIVONA TRACHEOSTOMY TUBE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10934789 ↗

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.