Elevated risk U.S. Food and Drug Administration

Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric recall: The securement flange of specific lots of the Bivona Neonatal/Pediatric

Recall published 2+ years ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: This can lead to tracheostomy displacement or decannulation.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
August 19, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Bivona
Product type
Medical devices

Products covered by this recall

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)

What the company announced

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: Global Complaint Management · Contact Information: [email protected] 1-(866)-216-8806 · Areas of Support: To report adverse events or product complaints
  • Smiths Medical Contact: Customer Service · Contact Information: [email protected] 1-(800)-259-5361 · Areas of Support: 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

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

What to do about Device

Bivona — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Remedy named in the notice: Smiths Medical Contact Customer Service; Contact Information [email protected] 1-(800)-259-5361; Areas of Support Questions about your product and/or replacement.

Company contact: Smiths Medical — Consumers: 1-(800)-259-5361, 1-(866)-216-8806, [email protected], [email protected] — Media: Harrison Richards, 949-366-4261, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Bivona medical devices recalled?

The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. This can lead to tracheostomy displacement or decannulation.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: Smiths Medical Contact Customer Service; Contact Information [email protected] 1-(800)-259-5361; Areas of Support Questions about your product and/or replacement.

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