Bivona XT25BS40NGF135NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887709148250), received between Nov 10, 2025 and Feb 18, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Degraded; Defective Component

  IT WAS STATED THAT INTERNAL WIRING BECAME EXPOSED, WHICH PROMPTED AN EMERGENCY TRACH CHANGE WHILE THE DEVICE WAS IN USE WITH THE PATIENT. THE EVENT TOOK PLACE IN A NEW LONG-TERM FACILITY CONNECTED TO (B)(6) AND WAS MANAGED BY A HEALTH PROFESSIONAL. THE MEDICAL INTERVENTION WAS REQUIRED BECAUSE THE PATIENT NEEDED AN EMERGENCY TRACH CHANGE. THERE WERE A PATIENT INVOLVEMENT AND NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377457 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT THE TUBE BROKE AFTER USE. THE TRACH TUBE WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510199 ↗

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.