FDA-Device2021-03-24Class I
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). 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 Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (
Hazard
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.
Sold states
Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam
Affected count
70 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). 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 Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1196-2021More Medtronic Perfusion Systems recalls
- FDA-Device2026-07-01Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus Evolution Tissue Stabilizer recalled for incorrect tubing assembly
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
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