Bivona ZU19BN45NGF065SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517190380), received between Jan 28, 2020 and Jan 28, 2020 — classified as 1 malfunction.

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

• MalfunctionJan 28, 2020Break; Material Separation; Material Integrity Problem; Material Split, Cut or Torn; Break; Material Separation; Material Integrity Problem; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA CUSTOM 4.5 U/C FLEXTEND TRACHEOSTOMY TUBE WAS IN USE WITH A PATIENT AT THEIR HOME. THE PATIENT'S MOTHER WAS PREPARING A PLANNED TUBE CHANGE FOR THE INDWELLING DEVICE AND NOTICED THE "PLASTIC PIECE INSIDE THE 15MM ISO WAS SHAVING OFF AND MISSING SOME CHUNKS OF PLASTIC". THE SAME ISSUE WAS NOTICED ON THE REPLACEMENT TUBE AS IT WAS CHECKED PRIOR TO PLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9638737 ↗

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.