Medtronic Issues Recall for Heparin Coated Equipment

Scott Kappes

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Last week fallout continued resonate from the recall of Baxter International's heart surgery medication heparin, as popular medical device maker, Medtronic, issued a recall for some disposable devices used during heart surgery. The devices are coated with Medtronic’s Carmeda BioActive surface that includes heparin. The company has not received any reports of injury from the devices, but said that they issued the recall as a precautionary measure.

The coating is used on blood oxygenators, reservoirs, pumps and other disposable products that are used during the bypass surgery, the company said.

At least 81 deaths have been linked to contaminated batches of heparin. These patients experienced classic signs of allergic reaction including swelling of larynx and plummeting blood pressure among other symptoms.

The FDA suspects that the contamination was a deliberate attempt to pass off a similar but much cheaper product as raw heparin. The contaminant, identified as chondroitin sulfate, is derived from animal cartilage and costs about 100 times less to produce than heparin, which is extracted from pig intestines.

Baxter claims that the contamination occurred somewhere in its Chinese supply line and was not detected sooner because of the close similarity to of the contaminant to heparin. Normal tests to ensure quality could not differentiate between chondroitin sulfate and actual heparin.