FDA MedWatch – Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface by Medtronic:

TOPIC: Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface by Medtronic: Class I Recall – Due to Possible High Levels of Endotoxins

AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy, Pediatrics

ISSUE: Medtronic is recalling the specified device due to potentially elevated levels of harmful bacteria called endotoxins. The use of a device with high endotoxin level may result in fever, infection, acute systemic toxic reaction, or death.

There have been no complaints, reports of injuries, or deaths related to this device issue.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface are used in newborns, infants, and small pediatric patients requiring cardiopulmonary bypass, a procedure that temporarily takes over the function of the heart and lungs during surgery. The oxygenator adds oxygen to the blood and removes carbon dioxide. The venous reservoir is used to support and improve blood circulation during cardiopulmonary bypass.

RECOMMENDATIONS: On February 4, 2021, Medtronic sent an Urgent Medical Device Recall notification to all affected customers. The notification instructed customers to:

• Identify and quarantine all unused affected products as listed in the notification and the Customer Notification Detail Report.
• Contact Medtronic Customer Service to initiate product return.
• Return all unused affected products to Medtronic.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.