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November 27, 2014

FDA issues ‘Class I’ recall on Medtronic device

A Medtronic Inc. device used to stimulate the brain in the treatment of neurological conditions has a potentially life-threatening flaw that prompted U.S. regulators to issue its highest-level warning, the Star Tribune reports.

The wires on the ends of Medtronic’s deep-brain stimulators can be damaged by a cap designed to protect the delicate electronics while they are being inserted, the Fridley-based company said Thursday in a news release. The wires can be harmed when the connections inside the cap are twisted during surgery or when the cap is removed, the company said.

The Star Tribune reports that the U.S. Food and Drug Administration classified the issue as a Class I recall, meaning there is a reasonable probability that the defect could cause serious health consequences or death.

Medtronic alerted physicians to the problem in February and has changed the manufacturing in an effort to fix the issue, a change that is under review by the FDA, the Star Tribune reports.

The company urges patients with questions to talk to their doctors.