Heparin Coated Medical Devices Linked to 11 Deaths

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Heparin Coated Medical Devices Linked to 11 Deaths

June 10th, 2008 amy

Eleven deaths and 86 cases of harmful side effects this year have been linked to use of medical devices containing heparin, the FDA reports.

Most of the cases involved heparin used to clean intravenous lines, said Karen Riley, a Food and Drug Administration spokeswoman, in a June 5 interview. Bloomberg News reports that the heparin associated with two of the 11 deaths wasn’t contaminated, and the FDA can’t say conclusively say how many of the other deaths and side effects involved tainted heparin, according to Riley.

Riley said she also couldn’t identify which companies’ products were associated with the deaths and side effects. In addition to Baxter, companies including the device maker Medtronic Inc. have voluntarily recalled products that may contain contaminated heparin. The side effects and deaths linked to medical devices occurred between Jan. 1 and May 14, according to the FDA’s Web site.

Since January 2007, 81 people have died after allergic reactions, the FDA said on April 21. Riley said the 11 deaths involving devices are “probably in addition” to the 81.

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