Medtronic Recalls Heparin-Coated Bypass Equipment
Medtronic Inc said on Wednesday it was voluntarily recalling some disposable devices used during cardiac bypass surgery because they have been found to be coated with contaminated traces of the blood-thinner heparin.
Medtronic said the devices are coated with its Carmeda BioActive surface, which includes heparin used to help prevent blood clots among patients undergoing bypass procedures.
The company said it has not received reports of any contamination-related physical harm linked to its Carmeda products, but it was recalling them as a precaution.
The coating is used on blood oxygenators, reservoirs, pumps and other disposable products that are used during the bypass surgery, the company said.
A company spokesman said the products have relatively small sales, and that a separate Medtronic line of disposable bypass-surgery products covered with a different biosurface called Trillium would remain on the market because they incorporate far smaller amounts of heparin.
Medtronic said the recall was in response to an April 8 recommendation by the U.S. Food and Drug Administration that medical devices employing heparin be checked with newly-developed tests to make sure the heparin is not tainted with potentially harmful contaminants.
The FDA issued its recommendation after reports of serious injury and death in patients who had received injectable heparin products containing high levels of a contaminant called oversulfated chondroitin sulfate.
The agency has collected reports that tainted heparin was used by at least 81 U.S. patients who died soon afterward. They had classic allergic reactions, with plunging blood pressure, swelling of the larynx and other severe symptoms.
Their cases forced manufacturer Baxter International to recall the commonly used blood-thinner and caused a diplomatic squabble between officials in the United States and China, where much of the world’s supply of heparin is made.
The chondroitin contaminant, derived from animal cartilage, has a structure very similar to that of heparin. Heparin is obtained from pig intestines. It thus cannot be identified with the tests normally used to inspect batches of heparin.
