Bivona XT16DS45NGF009SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517056471), received between Sep 19, 2019 and Sep 19, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA 4.5 TTS HYPERFLEX FLEXTEND TRACHEOSTOMY TUBE CUFF WAS NOT INFLATING PROPERLY WHILE IN USE WITH A PATIENT. THE REPORTER STATED THE PATIENT'S MOTHER WAS IN THE PROCESS OF A TRACHEOSTOMY TUBE CHANGE, BUT WAS UNABLE TO COMPLETE THE CHANGE OUT DUE TO THE EVENT. IT WAS ALSO REPORTED THE PATIENT HAD AN OLD TUBE IN THE HOUSE THAT WAS ABLE TO BE CLEANED AND USED UNTIL A NEW TUBE ARRIVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9090329 ↗
• MalfunctionSep 19, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA 4.5 TTS HYPERFLEX FLEXTEND TRACHEOSTOMY TUBE CUFF WAS NOT INFLATING PROPERLY WHILE IN USE WITH A PATIENT. THE REPORTER STATED THE PATIENT'S MOTHER WAS IN THE PROCESS OF A TRACHEOSTOMY TUBE CHANGE, BUT WAS UNABLE TO COMPLETE THE CHANGE OUT DUE TO THE EVENT. IT WAS ALSO REPORTED THE PATIENT HAD AN OLD TUBE IN THE HOUSE THAT WAS ABLE TO BE CLEANED AND USED UNTIL A NEW TUBE ARRIVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9090327 ↗

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.