Summary

Company Announcement Date:
August 19, 2024
FDA Publish Date:
September 04, 2024
Product Type:
Medical Devices

Reason for Announcement:

Recall Reason Description

The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

Company Name:
Smiths Medical
Brand Name:

Brand Name(s)

Product Description:

Product Description

Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s)

Company Announcement

MINNEAPOLIS, MN. August 19, 2024 – Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes.

All impacted customers and distributors were sent a letter outlining the risk and providing specific steps to determine whether their devices are affected or not and what steps to follow if they have affected product in service. A copy of that letter as well as a list of affected products can be accessed on ICU Medical’s website here.

The customer notification sent on May 29, 2024, indicated that if the flange on the item is torn or broken, the tracheostomy tube may not stay in position in the trachea. This can lead to tracheostomy displacement or decannulation. Either event may result in an inability to properly ventilate or protect the airway and may contribute to a catastrophic adverse event.

For further inquiries, please contact Smiths Medical using the information provided below

Smiths Medical Contact

Contact Information

Areas of Support

Global Complaint Management [email protected] 1-(866)-216-8806 To report adverse events or product complaints
Customer Service [email protected] 1-(800)-259-5361 Questions about your product and/or replacement

The U.S. Food and Drug Administration (FDA) has been notified of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Company Contact Information