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  5. Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
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Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Smiths Medical Tracheostomy Tube

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

  • Identify any affected products at the institution based on product codes and lot numbers.
  • Do not use affected products.
  • Dispose of affected products or quarantine them out of use.

On June 13, 2024, 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 smithsmedical8551@sedgwick.com 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.

Reason for Recall

Smiths Medical is recalling specific lots of the BLUSelect, BLUgriggs, and BLUperc products 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.

Device Use

The BLUselect tracheostomy tube (BLUselect) 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 (BLUgriggs) and BLUperc Percutaneous Diliation Procedural Tray with BLUselect trach tubes (BLUperc) 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.

Contact Information

Customers in the U.S. with questions about this recall should contact Smiths Medical customer service at 1-(800)-0258-5361 or Customerservice@icumed.com.

Full List of Affected Devices

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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