Medical Devices Made with Tainted Heparin Recalled by MedtronicMay 8, 2008 | Parker Waichman LLP
Medtronic Inc. is recalling some medical devices because they may be coated with tainted heparin, a drug linked to 81 deaths in the US. The disposable medical devices, used during cardiac bypass surgery, are made with Medtronic's Carmeda BioActive surface, which includes heparin. No injuries have been reported in relation to the Medtronic devices, but the recall underscores the enormous scope of the problems involving contaminated heparin.
Tainted heparin first garnered attention earlier this year, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in 11 other countries, including Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 81 to be exact - were associated with contaminated batches of heparin.
In March, the FDA confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Since then, researchers have been able to show that chondroitin sulfate can cause reactions like those seen among patients treated with tainted heparin.
In speaking with reporters after a Senate hearing last month, FDA Commissioner Andrew von Eschenbach said that while the agency has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.” It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
Medtronic says the Carmeda BioActive surface is used on blood oxygenators, reservoirs, pumps and other disposable products that are used during the bypass surgery. According to Reuters, Medtronic initiated the recall because of an April 8 recommendation by the FDA that medical devices employing heparin be checked with newly-developed tests to make sure the heparin is not tainted. Chondroitin sulfate cannot be identified with the tests normally used to inspect batches of heparin.
A separate Medtronic line of disposable bypass-surgery products covered with a different biosurface called Trillium will remain on the market because they incorporate far smaller amounts of heparin.