Bivona SU17GN40NGF123SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517116199), received between Nov 27, 2017 and Nov 27, 2017 — classified as 3 injuries.

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 27, 2017Break; Tear, Rip or Hole in Device Packaging; Torn Material; Break; Tear, Rip or Hole in Device Packaging; Torn Material

  THE EVENT OCCURRED WHILE THE PATIENT WAS SLEEPING OR "UP, AWAKE, AND [ACUTE]". THE DEVICE FAILED WITHIN 7 DAYS OF USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059705 ↗
• InjuryNov 27, 2017Break; Tear, Rip or Hole in Device Packaging; Torn Material; Break; Tear, Rip or Hole in Device Packaging; Torn Material

  IT WAS REPORTED THAT WHILE A PATIENT WAS USING A PORTEX® BIVONA CUSTOM TRACHEOSTOMY TUBE, THE FLANGE BROKE. AN EMERGENCY TRACH CHANGE WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059703 ↗
• InjuryNov 27, 2017Break; Tear, Rip or Hole in Device Packaging; Torn Material; Break; Tear, Rip or Hole in Device Packaging; Torn Material

  IT WAS REPORTED THAT WHILE A PATIENT WAS USING A PORTEX® BIVONA CUSTOM TRACHEOSTOMY TUBE, THE FLANGE BROKE. AN EMERGENCY TRACH CHANGE WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059699 ↗

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.