Medtronic Heparin-Coated Devices Recalled
Thursday, May 08, 2008
Medtronic Inc. announced on May 7, 2008 a recall of some devices used in heart bypass surgery because their coating includes small amounts of contaminated Heparin, a blood thinner that in larger doses has been linked to 81 deaths.Most of the Heparin recently recalled by other manufacturers was administered in large doses for patients getting heart surgery or dialysis. But Heparin is also used in much smaller quantities as a coating on devices such as stents or catheters.
Medtronic says its recall includes products such as blood oxygenators and tubing packs that were found with contaminated heparin. Medtronic's coating is called Carmeda BioActive.
It says it has not received any reports that anyone got sick from the devices, and it's not clear whether exposure at those levels would cause a problem.
On February 11, 2008, Baxter HealthCare Corp. announced that it would stop producing the blood thinner Heparin, after numerous reports of serious allergic reactions and patient deaths. Baxter produces half of the Heparin sold in the United States.