Bivona 67NFP35Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688518750), received between Dec 4, 2020 and Dec 30, 2024 — classified as 3 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.

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.

Recalls naming this device

1. May 29, 2024Class IOpen, 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-2608-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS TESTED PRIOR TO PLANNED TRACHEOSTOMY TUBE CHANGE AND WOULD NOT INFLATE. BOTH TUBES WERE FROM THE SAME BATCH. AS A REMEDIAL ACTION, A NEW TRACHEOSTOMY TUBE WITH EFFECTIVE CUFF WAS USED. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036574 ↗
• MalfunctionDec 21, 2020Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH WAS NOTED TO ONLY INFLATE THREE FOURTHS OF THE WAY AROUND LEAVING AN INCOMPLETE SEAL. ON FURTHER INSPECTION, THE CUFFS WERE ABLE TO BE INFLATED BUT THIS REQUIRED A SIGNIFICANT AMOUNT OF MANIPULATION TO ACHIEVE THIS. THE CUSTOMER IS WORRIED ABOUT STERILITY OF THE CUFFS IF THIS NEEDS TO BE DONE PRIOR TO INSERTION. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Information

  MAUDE report 11046686 ↗
• MalfunctionDec 4, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF FAILED TO INFLATE ON THE BIVONA TRACHEOSTOMY TUBE. THE PRODUCT PROBLEM WAS OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10949474 ↗

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.