Medtronic Voluntarily Recalls some Heparin Coated Products
Medtronic is initiating a voluntary recall of products featuring the Carmeda BioActive surface. This is in response to the U.S Food and Drug Administration’s recommendation to check any products that could contain the contaminated heparin linked to recalls early in the month of April. Affected products include blood oxygenators, reservoirs, pumps, cannulae and tubing packs. A limited number of lots of the Carmeda-coated products were manufactured with the oversulfated chondroitin sulfate contaminated heparin. So far 81 deaths have been associated with adverse reactions to the adulterated heparin as well as many reports of serious injury.
