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Cyber Risk Leads to Pacemaker Recall

PacemakerPatients who rely on implantable cardiac devices like pacemakers have plenty to worry about in their daily lives. The last thing they need is something else that could possibly go wrong. Unfortunately, nearly half a million patients recently found out that their pacemakers are potentially at risk of being hacked. In August of last year, the U.S. Food and Drug Administration (FDA) issued its first-ever medical device recall based on cybersecurity concerns.

The Dangers

According to various sources, the FDA recalled six pacemaker models—all of them manufactured by Abbott and distributed under the St. Jude Medical label. The total number of patients affected by the recall is estimated to be about 465,000.

The devices are equipped with radio frequency (RF) technology to assist doctors in managing their patients’ conditions. The presence of an RF receiver, however, seems to have left the pacemakers potentially susceptible to being hacked by someone with access to an RF transmitter. The FDA said that hackers could intentionally drain a device’s battery or change the pacing of the device. Either scenario could be fatal to the patient.

Fortunately, there have been no reports of any hacking incidents or patient injuries. The recall was issued as a precautionary measure.

What Can Patients Do?

Patients who have received the affected pacemakers will not have their devices replaced as a result of the recall. Instead, the FDA indicated that a firmware update should be performed the next time the patient visits his or her physician. The update—similar to a security update for a cell phone or other electronic device—will effectively eliminate the risk of the pacemaker being hacked.

A Brave new World

The first implantable pacemaker was designed in 1958 by a man named Wilson Greatbatch. Since then, there has been exponential growth in the use of technology—not only in medical fields but throughout the life of the average person. Today, we can connect our refrigerators, home thermostats, and even the locks on our front doors to the internet. Bands on our wrists can count our daily steps, track our heart rate, and provide GPS feedback on a run or bike ride.

With that in mind, the FDA’s first cyber risk recall is not likely to be its last. It is vitally important for patients who rely on medical devices to be aware of the potential dangers and to remain up to date on all notices, alerts, and recalls.

Call Us for Help

If you or someone you love has been injured by a recalled medical device, you may be entitled to collect compensation for your injuries. Contact an experienced San Jose defective medical device attorney to discuss your case and explore your available options. Call (408) 289-1417 for a free consultation at Corsiglia McMahon & Allard, L.L.P. today.

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