Bivona ST16LN35NGG954NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517087857), received between Dec 21, 2017 and Dec 21, 2017 — classified as 1 injury.

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

• InjuryDec 21, 2017Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT, WHEN CHANGING THE TIES ON THIS TRACHEOSTOMY TUBE, IT WAS NOTED THAT THE FLANGE WAS BROKEN. THIS WAS THE PATIENT'S SECOND TIME WEARING THIS CUSTOM TRACHEOSTOMY TUBE. THE TRACHEOSTOMY TUBE WAS CHANGED OUT FOR A NEW ONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7137588 ↗

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.