Bivona 67NFPS40Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10351688518804), received between Aug 29, 2019 and Jan 27, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (7 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-2609-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO TRACH¿S WERE REPORTED WITH THE ISSUE, THE CUFFS WERE NOT INFLATING PROPERLY, THE CUFF GOT STUCK ON ONE SIDE AND DOES NOT INFLATE FULL LIKE A BALLOON. RUSHED TWO MORE TRACHS (SAME LOT) AND THE CLIENT HAD THE SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241968 ↗
• MalfunctionJan 27, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO TRACH¿S WERE REPORTED WITH THE ISSUE, THE CUFFS WERE NOT INFLATING PROPERLY, THE CUFF GOT STUCK ON ONE SIDE AND DOES NOT INFLATE FULL LIKE A BALLOON. RUSHED TWO MORE TRACHS (SAME LOT) AND THE CLIENT HAD THE SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241927 ↗
• MalfunctionOct 18, 2024Inflation Problem; Inflation Problem

  IT WAS STATED THAT CUFF WOULD NOT INFLATE. THE TRACH WAS IN THE PATIENT WHEN THE INCIDENT OCCURRED. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20484214 ↗
• MalfunctionOct 18, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE. THE TRACH WAS IN THE PATIENT WHEN THE INCIDENT OCCURRED. THERE WAS NO PATIENT DEATH AND NO PATIENT INJURY. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483532 ↗
• MalfunctionNov 28, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF IS LEAKING. NO INJURY, NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870097 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THREE CUFFS WERE INFLATING ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437145 ↗
• MalfunctionDec 8, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO CUFFS WERE NOT INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960268 ↗
• MalfunctionDec 8, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO CUFFS WERE NOT INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960191 ↗
• MalfunctionDec 18, 2020Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH TUBE INFLATES ONLY THREE FOURTHS OF THE WAY AROUND WHICH LEFT AN INCOMPLETE SEAL. THE CUFFS WERE ABLE TO BE INFLATED BUT THIS REQUIRED A SIGNIFICANT AMOUNT OF MANIPULATION TO ACHIEVE THIS. THE CUSTOMER IS CONCERNED ABOUT STERILITY OF THE CUFFS IF THIS IS NEEDED TO BE DONE PRIOR TO INSERTION. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Information

  MAUDE report 11041137 ↗
• MalfunctionAug 29, 2019Separation Problem; Separation Problem

  INFORMATION WAS RECEIVED THAT ONE SIDE OF THE FLANGE OF A SMITHS MEDICAL TRACHEOSTOMY HAD SNAPPED OFF. NO FURTHER INFORMATION RECEIVED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946316 ↗

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.