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Medical device maker Medtronic has issued a voluntary recall of heparin-coated bypass equipment, including pumps, reservoirs and blood oxygenators. The company said the recall is a precautionary measure and that no reports of injuries have been linked to its products.

According to Medtronic, the recalled devices are coated with Carmeda BioActive—a substance that contains the blood thinning drug heparin. Coating the medical devices helps to reduce the risk of blood clots in patients undergoing heart bypass surgery.

FDA Investigates Heparin Contamination

Medtronic said the recall was prompted by a Food and Drug Administration recommendation. In recent months, the FDA has received reports of 81 deaths and hundreds of allergic reactions due to contaminated injectable heparin.

The FDA said the contamination occurred during the manufacturing process in China, which is where the majority of the world’s heparin is made. The contaminant was identified as oversulfated chondroitin sulfate.

It is still uncertain as to whether or not the contamination was intentional.

(Source: Reuters)

Injured by contaminated heparin? Contact an experienced attorney near you today to learn more about your legal options.