Bivona 67SN040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15021312000269), received between Jan 10, 2019 and Apr 24, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K083641, K914088); 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-2615-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2023Connection Problem; Material Split, Cut or Torn; Connection Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE A TRACH HAD A TORN FLANGE, THEY WERE UNABLE TO ATTACH THE "TRACHITIS". AN EMERGENT TRACH CHANGE WAS COMPLETED TO RESOLVE THE ISSUE. THE REPORTED LOT NUMBER WAS 4216394. VERIFICATION OF THE ITEM AND LOT NUMBERS HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16800815 ↗
• InjuryApr 24, 2023Connection Problem; Material Split, Cut or Torn; Connection Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE A TRACH HAD A TORN FLANGE, THEY WERE UNABLE TO ATTACH THE "TRACHTIES". AN EMERGENT TRACH CHANGE WAS COMPLETED TO RESOLVE THE ISSUE. THE REPORTED LOT NUMBER WAS 4216394. VERIFICATION OF THE ITEM AND LOT NUMBERS HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16800171 ↗
• MalfunctionOct 3, 2019Output Problem; Output Problem

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, PATIENT HAD LOW BLOOD OXYGEN AND WAS IRRITABLE. THE INCIDENT REQUIRED BAGGING AND INCREASED OXYGEN. IT WAS REPORTED THE PATIENT REQUIRED A TRACHOESTOMY TUBE CHANGE OUT TO SUSTAIN LIFE; THE PATIENT THEN RECOVERED. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: Irritability; Low Oxygen Saturation

  MAUDE report 9153128 ↗
• MalfunctionJan 10, 2019Unintended Movement; Unintended Movement

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL PORTEX® BIVONA® TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS BROUGHT TO MAGNETIC RESONANCE IMAGING (MRI). IT WAS REPORTED THAT THE PATIENT WAS GRABBING AT THEIR THROAT AND THE TUBE HAD STARTED TO COME OUT. SUBSEQUENTLY, THE TRACH WAS CHANGED OUT FOR AN MRI SAFE TRACH AND WAS DISCARDED. THE PACKAGING OF THE TUBE WAS NOTED NOT TO STATE THAT THE TUBE WAS MRI "CONDITIONAL" AS THE WEBSITE STATES IT SHOULD BE. THE PATIENT RECOVERED WITH NO ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8238561 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K914088. One submission often covers many models, so check the product and lot details in each record.

• Z-0205-2024 · Aug 22, 2023 · Open, Classified
  Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Z-2946-2020 · Aug 28, 2020 · Terminated
  Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
• Z-1465-2017 · Feb 9, 2017 · Terminated
  Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
• Z-0930-05 · Apr 26, 2005 · Terminated
  Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
• Z-0302-06 · Feb 17, 2005 · Terminated
  Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.