The agency is instructing patients with certain implantable cardiac pacemakers from St. Jude Medical – now owned by Abbott Laboratories – to visit their physicians for firmware updates to address cyber vulnerabilities that can potentially be remotely exploited by hackers and that pose safety concerns.Approximately 465,000 such devices are in use in the U.S., an Abbott spokeswoman tells Information Security Media Group. She did not immediately have information about how many of these devices are used outside the U.S.While the FDA has characterized the corrective action to address the vulnerabilities as a “voluntary recall” by the manufacturer, the Abbott spokeswoman stresses that neither the company nor the FDA is not recommending the “prophylactic removal and replacement of affected devices.” Rather, patients are being advised to have the devices’ firmware updated “at their next regularly scheduled visit” to their healthcare provider, the Abbott spokeswoman says.

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