Bivona 65SP045Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15021312000313), received between May 17, 2018 and Sep 20, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 29, 2024Open, Classified

   Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

   Z-2605-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING USE ON A PATIENT, A CRACK APPEARED IN THE HOLE OF THE FLANGE WHERE THE NECK TAPE PASSES. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273259 ↗
• MalfunctionDec 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE, THE PATIENT PULLED THE INFLATION LINE AND TORE IT. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12981432 ↗
• MalfunctionDec 10, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT URING USE, THE PATIENT PULLED THE INFLATION LINE AND TORE IT. NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12978693 ↗
• MalfunctionMay 17, 2018Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A CUFF TO A SMITHS MEDICAL PORTEX® BIVONA® AIRE-CUF® TRACHEOSTOMY TUBE WAS NOTED TO DEFLATE EASILY 12 DAYS FOLLOWING PLACEMENT. IT WAS REPORTED THAT 1.2 MLS OF AIR WAS INSTILLED INTO THE CUFF THE TRACH AND DECREASED TO 0.5 MLS IN TWO HOURS. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7523477 ↗