Bivona ST18JN60NSZ165NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517169744), received between Nov 15, 2019 and Nov 15, 2019 — classified as 1 injury.

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

• InjuryNov 15, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX BIVONA CUSTOM FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE, THE CUFF WAS OBSERVED TO NOT BE INFLATING PROPERLY. THE PATIENT WAS REPORTED TO NOT BE GETTING THE APPROPRIATE TIDAL VOLUME NEEDED AND THEIR RESPIRATORY RATE WAS 30-35 RESPIRATIONS A MINUTE. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED. THE PATIENT RECOVERED WITH NO FURTHER ADVERSE PATIENT EFFECTS.

  Patient problems: Increased Respiratory Rate

  MAUDE report 9329290 ↗

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.