FDA Recalls Nearly Half a Million Pacemakers Over Security Concerns

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A review by FDA found serious vulnerabilities in six devices by Abbott.

The Food and Drug Administration has issued a warning calling for a voluntary recall of more than 465,000 pacemakers implanted in patients.

In a review, the FDA found potential vulnerabilities in Abbott’s (formerly St. Jude Medical’s) RF-enabled implantable cardiac pacemakers. Affected devices include Accent, Anthem, Accent MRI, Accent ST, Assurity Allure.

If the vulnerabilities were exploited, an attacker could gain access to a patient's device and then hurt the patient by either depleting the battery or triggering fatal pacing.

What’s the fix? A firmware update patches these vulnerabilities; however, considering the nature of the device, you can’t update it at home. The FDA said that the update requires an in-person patient visit with a health care provider.

The good news is that they don’t have to operate on the patient to take out the device. The patch will take place wirelessly in about three minutes.

“During this time, the device will operate in backup mode (pacing at 67 beats per minute), and essential, life-sustaining features will remain available. At the completion of the update, the device will return to its pre-update settings,” the FDA said in its advisory.

The firmware update was made available on August 29, 2017. All Pacemakers manufactured after this date will have the patch pre-loaded in the device and will not need the update.

If you or your friends or family members have a pacemaker implant, please check the advisory to stay safe.

09/11/2017

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