The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface
- Model BBP241
- Lot: 13340434
- Perfusion Tubing Packs built with the affected Affinity Pixie™ CVR
- Models: BB10H89R4, HY10J00R6, HY11B40R1
- Lots: 220265395, 220768819, 220911913
- Distribution Dates: April 29, 2020 to November 20, 2020
- Devices Recalled in the U.S.: 126
- Date Initiated by Firm: February 4, 2021
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.
Reason for Recall
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.
Who May be Affected
- Health care providers using the affected Medtronic device
- Patients who undergo procedures using the affected device
What to Do
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 at 800-854-3570 to initiate product return.
- Return all unused affected products to Medtronic.
- Complete the Customer Confirmation Form included with the notification and email it to firstname.lastname@example.org.
Customers with questions about this recall should contact Medtronic Customer Service at 800-854-3570.
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 using an online form, regular mail, or FAX.