Bivona FT19CN45NGF923NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517186055), received between Aug 29, 2019 and Oct 8, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryOct 8, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE HAD ISSUES WITH THE HUB AND WAS REPORTED TO BE CRACKING AND PULLING AWAY FROM THE TUBE. THE REPORTER ALSO STATED THAT WHEN LOOKING AT THE OTHER TWO DEVICES THEIR BOX, THEY "NOTICED THAT THE PLASTIC PIECES INSIDE THE HUBS WERE CRACKED". SUBSEQUENTLY, A TUBE CHANGE OUT WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9168108 ↗
• InjuryAug 29, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE HAD ISSUES WITH THE HUB AND WAS REPORTED TO BE CRACKING AND PULLING AWAY FROM THE TUBE. SUBSEQUENTLY, A TUBE CHANGE OUT WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946962 ↗

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.