Bivona HU16DS50NSA245NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517144352), received between Jun 26, 2019 and Jun 26, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• MalfunctionJun 26, 2019Inadequacy of Device Shape and/or Size; Material Integrity Problem; Inadequacy of Device Shape and/or Size; Material Integrity Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA CUSTOM TRACHEOSTOMY TUBE MATERIAL IS "RUBBING" WHILE IN USE WITH A PATIENT. IT WAS ALSO NOTED THAT THE PATIENT'S MOTHER OBSERVED AN APPEARANCE OF "BUBBLES/NODULES ON ONE SIDE". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 8733176 ↗

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.