A manufacturing defect may cause the pilot balloon to disconnect from the tracheostomy inflation line. 

RT’s Three Key Takeaways:

  1. Recall Due to Defect: Smiths Medical is recalling certain BLUSelect, BLUgriggs, and BLUperc tracheostomy tube kits because of a defect that may cause the pilot balloon to disconnect from the inflation line, which could prevent proper ventilation.
  2. Serious Health Risks: The defect poses serious health risks, including inadequate ventilation, increased aspiration risk, and potential death. So far, 12 injuries have been reported, with no deaths.
  3. FDA Class I Recall: This recall is classified as a Class I—the most serious type—by the FDA, and Smiths Medical has issued guidance for customers on identifying and discarding affected products.

Smiths Medical is recalling specific lots of the BLUSelect, BLUgriggs, and BLUperc tracheostomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the tracheostomy inflation line. 

If the pilot balloon used to inflate the tracheostomy cuff disconnects, pressure may not be maintained, which can lead to inadequate ventilation and increased risk of aspiration. The use of affected product may cause serious adverse health consequences, including aspiration and death.

There have been 12 reported injuries. There have been no reports of death. This recall involves removing certain devices from where they are used or sold. The US Food and Drug Administration has identified this recall as Class I, the most serious type. 

The BLUselect tracheostomy tube is a polyvinyl chloride (PVC) tracheostomy tube for adults who need an artificial airway after trauma or due to a medical condition. The BLUgriggs percutaneous dilation procedural tray with BLUselect trach tubes and BLUperc percutaneous diliation procedural tray with BLUselect trach tubes are also used for adults who need an artificial airway after trauma or due to a medical condition but are available in kits that include additional proprietary procedural components to help health care providers with tracheostomy insertion.

Affected product:

  • Product Names:
    • BLUselect Tracheostomy Tube Kits
    • BLUselect Suctionaid Tracheostomy Tube Kits
    • BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without Forceps
    • BLUperc Dilation Procedural Tray with Single Stage Dilator Products
    • BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube
  • Lot/Serial Numbers: See full list of affected products

What to Do

On June 13, Smiths Medical sent all affected customers an Urgent Medical Device Notification letter recommending the following actions:

  • Check all inventory for the specific lots of the affected product codes and discontinue use.
  • Discard all affected products following the institution’s process for disposal.
  • Quarantine products if disposal is not immediately available.
  • Share the notification with all potential device users, including at other locations where the devices may be used.
  • Complete and return the customer response form to [email protected] within 10 days of receipt.
  • Contact your local representative for replacement product and/or a credit.
  • Distributors should immediately forward the notice to any customers who may have received affected product.

Customers in the US with questions about this recall should contact Smiths Medical customer service at 1-(800)-0258-5361 or [email protected].