Bivona HU20IS55NSF064NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517242362), received between Feb 17, 2022 and Feb 17, 2022 — classified as 1 injury.

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

• InjuryFeb 17, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THERE WAS AN UNPLANNED TRACHE CHANGE DUE TO RESPIRATORY DISTRESS AND REDUCED OXYGEN SATURATIONS. THE CUSTOMER FELT IT TO BE A BLOCKED TUBE. WHEN THE PARENT INITIALLY INSERTED THIS TUBE, ALL WAS WELL BUT WHEN THE PARENT ATTEMPTED TO PASS SUCTION CATHETER DOWN TRACHE THEY WERE UNABLE TO ADVANCE THE CATHETER. THE TRACHE TAPES RELEASED AND ABLE TO PASS SUCTION CATHETER EASILY, BUT UNABLE TO PASS SUCTION CATHETER WHEN SECURED AT NORMAL TENSION. AS A TEMPORARY MEASURE, THE TRACHE WAS SECURED AT A MUCH LOOSER TENSION. A NEW TUBE FROM A DIFFERENT BATCH NUMBER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 13552839 ↗

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.