Smiths Medical Trach Tubes May Disconnect From Pilot Balloon, Leading to Severe Injury or Death

Defects in certain BLUselect, BLUgriggs and BLUperc tracheostomy tube kits may pose ventilation and aspiration problems, which have already led to 12 reported injuries.

An urgent medical device notification has been issued about problems with certain Smiths Medical tracheostomy tube kits, which could fail to maintain pressure, posing a risk of serious and potentially life-threatening injuries.

The U.S. Food and Drug Administration (FDA) announced the Smiths Medical Tracheostomy Tube recall on October 25, warning healthcare professionals to stop using certain certain BLUselect, BLUgriggs and BLUperc kits, and dispose of the recalled models.

The Smiths Medical trach tubes are used for adults in hospitals and outpatient centers, to provide an artificial airway after trauma or due to a medical condition. The procedural trays included in certain tracheostomy tube kits also help health care providers with tracheostomy insertion.

The trach tube recall occurred after discovering a manufacturing defect that may cause the pilot balloon from the tubes’ insertion trays to disconnect from the inflation lines.

The pilot balloon on a trach tube lets the provider confirm whether the tube’s cuff is inflated or deflated, allowing them to be certain the tube is sealed and no outside materials are being inhaled into the lungs. When the balloon disconnects from the tube, it can lead to low pressure, inadequate ventilation and a higher risk of aspiration.

Smiths Medical first sent a letter (PDF) to customers about the potential problem on June 13, indicating that they had received reports involving at least 12 injuries linked to the tracheostomy tube pilot balloon defect.

While no deaths have been reported in connection with the recalled trach tubes, the FDA has categorized this action as a Class I recall, which is the most serious type, indicating that continued use of the product could cause serious injury or death.

The warning impacts the following products, with specific lot numbers listed on the FDA recall notice:

• BLUselect Tracheostomy Tube Kits
• BLUselect Suctionaid Tracheostomy Tube Kits
• BLUperc Dilation Procedural Tray with Single Stage Dilator Products
• BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube
• BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without Forceps

As a result of the product defect, Smiths Medical is urging all customers who have a recalled trach tube kit to stop using and dispose of the product. Affected products that cannot be disposed of immediately should be quarantined until disposal can be arranged.

Health care providers are asked to share the recall notification with all potential device users, including other locations where the device may be used.

Users are also advised to complete and return the Customer Response Form attached to the notification letter within 10 days of receipt. Completed forms can be sent to smithsmedical8551@sedgwick.com. Consumers may contact their local representative for a replacement product and/or a credit.

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.

Health care professionals and other customers can also report any adverse reactions or quality problems they experience to the FDA’s Safety Information and Adverse Event Reporting Program, MedWatch.