Bivona ZT18BN65NSC102NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517142259), received between Jun 18, 2018 and Jun 18, 2018 — classified as 1 injury, 1 malfunction.

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

• InjuryJun 18, 2018Break; Break

  IT WAS REPORTED THAT THE SWIVEL PART OF BIVONA TUBES CUSTOM WAS BROKEN. A REPLACEMENT DEVICE WAS URGENTLY REQUESTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS IN THE HOSPITAL SINCE (B)(6), AND THAT THE AFOREMENTIONED ISSUE "HAS SLOWED HIS THERAPY THEREFORE SLOWING HIS RELIEF." NO FURTHER COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7611403 ↗
• MalfunctionJun 18, 2018Break; Break

  IT WAS REPORTED THAT THE SWIVEL PART OF BIVONA TUBES CUSTOM WAS BROKEN. A REPLACEMENT DEVICE WAS URGENTLY REQUESTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS IN THE HOSPITAL SINCE (B)(6), AND THAT THE AFOREMENTIONED ISSUE "HAS SLOWED HIS THERAPY THEREFORE SLOWING HIS RELIEF." NO FURTHER COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7611388 ↗

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.