Bivona FT16HN55NGF088NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517068764), received between Mar 2, 2017 and Nov 28, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2017Break; Break

  IT WAS REPORTED THAT WHILE A PATIENT WAS USING A PORTEX® BIVONA® CUSTOM 5.5 TTS¿ FLEXTEND¿ TRACHEOSTOMY TUBE, THE CUFF BROKE. AN EMERGENCY TRACH CHANGE WAS PERFORMED. THE PATIENT IS VENTILATOR DEPENDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; Ventilator Dependent

  MAUDE report 7062804 ↗
• MalfunctionMar 2, 2017Break; Break

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE "NECK CIRCLE PIECE" BROKE ON THE RIGHT SIDE AT THE TRACHEOSTOMY TUBE TIES. THE TUBE BROKE WHEN THE NURSE ATTEMPTED TO INSERT THE TRACHEOSTOMY TUBE IN THE STOMA. THE TUBE WAS REPLACED TO ADDRESS THE ISSUE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00602.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6371908 ↗
• MalfunctionMar 2, 2017Break; Break

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE "NECK CIRCLE PIECE" BROKE ON THE RIGHT SIDE AT THE TRACHEOSTOMY TUBE TIES. THE TUBE BROKE WHEN THE NURSE ATTEMPTED TO INSERT THE TRACHEOSTOMY TUBE IN THE STOMA. THE TUBE WAS REPLACED TO ADDRESS THE ISSUE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00603.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6371903 ↗

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.