Bivona 67PFPS55Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10351688518576), received between Nov 17, 2023 and Nov 20, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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-2612-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Gas/Air Leak; Air/Gas in Device; Gas/Air Leak; Air/Gas in Device

  IT WAS REPORTED THAT THE PARENTS OF THE PATIENT INFORMED THE CUSTOMER THAT AN EMERGENCY TRACHEOSTOMY CHANGE HAD TO BE PERFORMED DUE TO THE BALLOON FAILURE ON THE CHILD'S TUBE. THE TUBE HAS ONLY BEEN CHANGED TWICE PREVIOUSLY, ON (B)(6) 2025 AND (B)(6) 2025. THE EVENT OCCURRED AT THE SPACE CENTRE FOR CHILDREN WITH COMPLEX NEEDS. THE PROVIDED PATIENT DETAILS ARE AS FOLLOWS: INITIALS - MSA, AGE - 10 YEARS 7 MONTHS, GENDER - MALE, WEIGHT ¿ 39,4KGS AND ETHNICITY/RACE ¿ BRITISH ASIAN. THERE WAS PATIENT INVOLVEMENT AND NO HARM. A SIMILAR COMPLAINT FROM THE CUSTOMER HAS BEEN DOCUMENTED UNDER CN-364723.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604797 ↗
• MalfunctionNov 12, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS NOT FULLY DEFLATED, ONLY ONE SIDE WAS INFLATED, AND THE PATIENT WAS HARMED DUE TO AIR LEAKAGE AROUND THE TRACHEA. REPORTER STATED THE OUTCOME WAS STILL ONGOING, AND INDICATED DAMAGE WAS OBSERVED ON THE CUFF AND RESULTING IN THE LEAKAGE. ANY ADVERSE EVENTS OF THE PEDIATRIC PATIENT AS A RESULT OF THE AIR LEAKAGE WERE NOT INDICATED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533462 ↗
• MalfunctionNov 12, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS NOT FULLY DEFLATED, ONLY ONE SIDE WAS INFLATED, AND THE PATIENT WAS HARMED DUE TO AIR LEAKAGE AROUND THE TRACHEA. REPORTER STATED THE OUTCOME WAS STILL ONGOING, AND INDICATED DAMAGE WAS OBSERVED ON THE CUFF AND RESULTING IN THE LEAKAGE. ANY ADVERSE EVENTS OF THE PEDIATRIC PATIENT AS A RESULT OF THE AIR LEAKAGE WERE NOT INDICATED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533456 ↗
• MalfunctionNov 12, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS NOT FULLY DEFLATED, ONLY ONE SIDE WAS INFLATED, AND THE PATIENT WAS HARMED DUE TO AIR LEAKAGE AROUND THE TRACHEA. REPORTER STATED THE OUTCOME WAS STILL ONGOING, AND INDICATED DAMAGE WAS OBSERVED ON THE CUFF AND RESULTING IN THE LEAKAGE. ANY ADVERSE EVENTS OF THE PEDIATRIC PATIENT AS A RESULT OF THE AIR LEAKAGE WERE NOT INDICATED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 23533368 ↗
• MalfunctionMar 7, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE ROUTINE 3-HOURLY CUFF RELIEF, WHICH INVOLVES DEFLATING AND REFLATING BALLOON WITH 3.5ML OF WATER PATIENT'S MOTHER ENCOUNTERED DIFFICULTIES WITH THE VALVE. SHE STATED THAT THE VALVE WAS A VERY TIGHT FIT WHEN SHE INSERTED THE SYRINGE, REQUIRING BOTH HER AND CAREGIVERS TO APPLY SIGNIFICANT PRESSURE TO THE TUBE. THE TUBE WAS REPORTED TO BE USED ONCE OVER A 14-DAY PERIOD. THE EVENT HAPPENED AT THE PATIENT'S HOME. THERE WERE UNKNOWN ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546400 ↗
• MalfunctionNov 17, 2023Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT IMMEDIATELY ON USE, THE DEVICE WAS FOUND TO HAVE A "DEFECTIVE CUFF". NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160333 ↗

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.