MINNEAPOLIS - Medtronic, Inc. voluntarily recalled selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. However, the U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS. In a separate action, Medtronic advised customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products.20The amount of heparin on the product is significantly lower than that contained on the Carmeda product.