Bivona ZT18EN80NSC134NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517153057), received between Jul 19, 2018 and Jul 19, 2018 — classified as 1 malfunction.

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

• MalfunctionJul 19, 2018Defective Component; Defective Device; Defective Component; Defective Device

  IT WAS INITIALLY REPORTED THAT THE BIVONA CUSTOM TUBE HAD PIN HOLES IN THE CUFF. THE TUBE WAS NEVER STERILIZED, AND HAD NO LEAK PRIOR TO PLACEMENT. IT WAS LATER REPORTED BY THE PATIENT'S PHYSICIAN THAT THERE WAS A CARTILAGE IN THE END USER'S TRACHEA THAT WAS DAMAGING THE CUFF. THE PHYSICIAN SUBMITTED A NEW TEMPLATE FOR A DEVICE WITH A LONGER LENGTH SHAFT, SO THAT THE CUFF WAS POSITIONED PAST THE CARTILAGE WHEN THE DEVICE WAS IN SITU. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7703775 ↗

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.