A Medtronic recall has been issued for various disposable cardiac bypass surgery devices which may be coated with heparin that is contaminated. The blood thinner may contain a fake ingredient known as oversulfated chondroitin sulfate. This is the same contaminant which has previously led to a nationwide Baxter recall for injectable heparin.
At least 81 people in the United States have died as a result of severe allergic reactions associated with contaminated heparin since January 2007. The FDA has indicated that the problems were likely caused by a manufacturing plant in China which provided raw ingredients with a substitute chemical. As a result of the widespread heparin contamination, the FDA indicated last month that all medical devices using heparin should be checked to determine if they contain the fake ingredient.
Medtronic, Inc. issued the recall since potentially contaminated heparin was used on blood oxygenators, reservoirs, pumps and other products they sold for use during heart bypass surgery. All of the devices are coated with Medtronic’s Carmeda BioActive surface, which uses the blood thinner to reduce the risk of clots during surgery. The medical device manufacturer indicates that all of the products involved in this recall had a low volume of sales.
Most of the reported heparin problems that have surfaced over the past year have been associated with injections administered during cardiac bypass surgery or dialysis treatment, which often involves larger doses of the blood thinner. Heparin lawsuits are being pursued throughout the United States by individuals who have suffered severe physical injury or death as a result of contaminated heparin.