Bivona CM3294NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517081428), received between Sep 11, 2017 and Sep 11, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Inflation Problem” (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 16, 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.

• InjurySep 11, 2017Material Fragmentation; Inflation Problem; Material Fragmentation; Inflation Problem

  IT WAS REPORTED THAT A RED RUBBER PART SNAPPED OFF CAUSING BALLOON NOT TO INFLATE ON A PORTEX® BIVONA CUSTOMIZATION TRACHEOSTOMY TUBE. THIS WAS A REGULAR TRACHEOSTOMY CHANGE, BUT AN EMERGENCY CHANGE WAS PERFORMED AFTER CUFF WOULD NOT INFLATE. THERE WAS NO PATIENT INJURY WITH THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6856008 ↗

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.