Bivona XT15GS40NGF181NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688853783), received between Mar 28, 2017 and Mar 28, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Physical Resistance” (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.

• InjuryMar 28, 2017Split; Physical Resistance; Split; Physical Resistance

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE SPLIT INTO TWO AFTER A FEW HOURS OF USE. THE ISSUE WAS OBSERVED BY THE PATIENT'S MOTHER EARLY IN THE DAY DURING ATTEMPT TO SUCTION THE PATIENT. IT WAS NOTED THAT THE PATIENT'S MOTHER ENCOUNTERED RESISTANCE IN THE TUBE. THE TUBE CUFF WAS FILLED WITH AIR. THE TRACHEOSTOMY TUBE WAS CHANGED IMMEDIATELY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439286 ↗

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.