Bivona 67PFP45Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688518507), received between Jan 14, 2025 and Jun 4, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 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-2611-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionJun 4, 2026Break

  IT WAS STATED THAT THE TRACH WAS DEFECTIVE. THE CUFF BROKE OFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392229 ↗
• MalfunctionJan 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ON THE TRACH WAS BROKEN AND COULD NOT INFLATE. STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS ALSO UNKNOWN. THE PRODUCT FAULT OCCURRED AT NIGHTTIME WHEN TRYING TO INFLATE THE TRACH AND SAW THAT THE CUFF WOULD NOT HOLD ANY AIR. THERE WERE NO NEGATIVE HEALTH OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150457 ↗

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.