Bivona XT15AS45NGA116SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688849946), received between Mar 17, 2017 and Mar 17, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionMar 17, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE FIRST DAY OF PLACEMENT OF THE BIVONA® CUSTOMIZED 4.5MM TTS¿ FLEXTEND¿ TRACHEOSTOMY TUBE, THE NURSE OBSERVED A LEAK IN THE DEVICE CUFF AND THE CUFF WOULD NOT REMAIN INFLATED. ACCORDING TO THE REPORT, IT WAS OBSERVED THAT WATER WAS LEAKING FROM THE CUFF. AFTER THE LEAK WAS NOTED, THE DEVICE WAS REPLACED AND THE EVENT WAS RESOLVED. THE REPORTED ISSUE OCCURRED DURING THE INITIAL USE OF THE DEVICE AND THE DEVICE CUFF WAS FILLED WITH STERILE WATER. IT WAS REPORTED THAT NO PATIENT INJURY OCCURRED AND THAT NO MEDICAL TREATMENT WAS PROVIDED DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6415263 ↗

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.