Bivona ZT17LN55ZGZ040NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517136654), received between Nov 1, 2019 and Nov 1, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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 1, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE WAS OBSERVED TO NOT BE HOLDING WATER. IT WAS REPORTED THAT 1.8MLS OF WATER WAS INITIALLY PUT IN, BUT WHEN CHECKED ONLY 1ML WAS REMAINING. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED. FOLLOWING REMOVAL FROM THE PATIENT, ALL THE WATER WAS FOUND IN THE EXTERNAL CUSHION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268968 ↗

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.