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FDA says recalled Medtronic guidewires potentially fatal

Started by riky, November 17, 2013, 09:00:20 AM

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riky

FDA says recalled Medtronic guidewires potentially fatal

(Reuters) - The U.S. Food and Drug Administration believes there is a reasonable probability that use of lots of Medtronic Inc's medical guidewires that were recalled in October could be fatal, the medical device maker said on Friday. Medtronic spokesperson Joseph McGrath said the company started recalling 14,896 guidewires, or 181 lots, in the week of October 21, after receiving four complaints, including one patient injury, of the coating on the surface of the guidewires detaching. The guidewires covered by the recall are designed to facilitate percutaneous coronary interventions, or the placement of left ventricular leads for cardiac rhythm devices, Medtronic said in a statement.

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