Bivona 67NFP40Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10351688518767), received between Jan 3, 2022 and Jun 15, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (5 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 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-2608-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS UNABLE TO BE INFLATED. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS A PATIENT INVOLVED BUT NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503605 ↗
• MalfunctionAug 13, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A TRACH WAS DISLODGED DURING PATIENT TRANSFER FROM BED TO SCALE. FOLLOWING CODE EVENT, THE NURSE INSPECTED TRACH AND NOTED THAT THE CUFF HAD 1.5ML OF WATER AND THE TRACH DID NOT INFLATE. THE NURSE THEN FILLED IT AT ITS MAXIMUM CAPACITY OF 3ML, THUS TRACH STILL DID NOT INFLATE ALL THE WAY AROUND. AFTER THE PATIENT WAS STABILIZED, THEY TRIED TO USE AN ADDITIONAL PRODUCT TO RESOLVE THE ISSUE BUT TO NO AVAIL. THERE WAS PATIENT INVOLVEMENT AND OUTCOME OF THE INJURY IS STILL ONGOING. CPR(CARDIOPULMONARY RESUSCITATION) AND INCREASED PATIENT CARE NEEDED ARE LISTED AS MEDICAL INTERVENTION.

  Patient problems: Cardiac Arrest

  MAUDE report 22798346 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THREE TRACH TUBE CUFFS ARE NOT INFLATING PROPERLY DESPITE CUFF MANIPULATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437943 ↗
• MalfunctionJan 3, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE WHEN CHECKING PRIOR TO THE PATIENT TRACH CHANGE.

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

  MAUDE report 13142897 ↗
• MalfunctionJan 3, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE WHEN CHECKING PRIOR TO THE PATIENT TRACH CHANGE.

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

  MAUDE report 13142863 ↗

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.