Medtronic Affinity Pixie Oxygenator (Medtronic) – Bacterial Endotoxin Risk (2021)
Elevated bacterial endotoxin levels may cause acute inflammatory response in patients.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Bala
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
13337110, 13337675, 13339043, 13339133, 13339290, 13339452, 13339527, 13344325, 13344487, 13344594, 13344819, 13346564, 13346733, 13347774, 13347907, 13347974, 13348151, 13348285, 13348909, 13348974, 13349283, 13349388, 13349517, 13349775, 13352983, 13353438, 13353541, 13353701, 13353800, 13337512, 13340766, 13342814, 13346440, 13348521, 13349141, 13352832, 13353163, ***UPDATE 13340871***.
Products Sold
Description: OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU. Model Number: BBP241. GTIN: 20613994746508 and ***UPDATE GTIN 00643169089037***: Lot Numbers: 13344059, 13337110, 13337675, 13339043, 13339133, 13339290, 13339452, 13339527, 13344325, 13344487, 13344594, 13344819, 13346564, 13346733, 13347774, 13347907, 13347974, 13348151, 13348285, 13348909, 13348974, 13349283, 13349388, 13349517, 13349775, 13352983, 13353438, 13353541, 13353701, 13353800, 13337512, 13340766, 13342814, 13346440, 13348521, 13349141, 13352832, 13353163, ***UPDATE 13340871***.
Medtronic Perfusion Systems is recalling Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosur due to Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may deve. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Recommended Action
Per FDA guidance
A written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. Consignees will also be asked to return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at800-854-3570 to initiate a product return.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026