Medtronic is recalling some Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface devices and Perfusion Tubing Packs because of potentially elevated levels of bacterial endotoxin.
The single-use cardiotomy/venous reservoir (CVR) is designed to collect and store blood during extracorporeal circulation. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion.
“Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response,” the US Food and Drug Administration (FDA) says in a recall notice.
The FDA is categorizing the recall as class 1, the most serious type. The company reports receiving no complaints related to the products through January 14 of this year.
The FDA says no additional actions are required for patients in whom the products were used during the procedure.
The affected devices are the Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface model #BBP241 and the Perfusion Tubing Packs built with the affected Affinity Pixie CVR models #BB10H89R4, #HY10J00R6, and #HY11B40R1.
Individual lot numbers can be found on the FDA website. The recall involves 2326 units distributed in 24 countries including the United States.
In an urgent medical device recall notice, Medtronic asks customers to not use any affected product and remove and quarantine all unused affected products in inventory.
Affected products should be returned to Medtronic. Customers with questions may contact Medtronic customer service by phone at 1-800-854-3570 (US toll free).
Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.