Covidien, LLC Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.

Recommended Action

Per FDA guidance

On 6/2/23, Medtronic sent recall notices to customers who were informed of the following: 1) If product was purchased directly from Medtronic, return affected product to Medtronic. 2) If product was purchased from a distributor, return affected product to the distributor. 3) The recall notice should be passed on to all who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 4) Complete and return the Customer Confirmation Form to rs.gmbfcamitg@medtronic.com Adverse reactions or quality problems experienced with this product can be reported to Technical Support at dl.gi-usdl-ustecchsupport@medtronic.com or call 1-800-448-3644 option 3.