Pacemakers recalled by FDA Due to Hacking Vulnerabilities

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close up of a pacemaker in a hospital
Pacemakers recalled for vulnerabilities

The Food and Drug Administration (FDA) in the United States has recalled nearly half a million pacemakers because they carry vulnerabilities that could put patients’ lives at risk.

Fears arise that the security bugs can lead to potential hacking, which would ultimately cause false alarms such as altering the patient’s heartbeat and draining the battery of the device.

Of course, if a hacker with ill intentions can gain access to the database or servers that facilitate the operations of the pacemakers, then the lives of nearly half a million patients will be at the hacker’s mercy.

Consequently, this could see hackers who have infiltrated the database demand for millions of payments in Bitcoins, or else they do the unthinkable.

Of course, due to the nature of cyber activities perpetuated in past instances, one cannot forgo the fact that such individuals with an inhumane character actually exist.

Now that the security flaws have been brought to light, the FDA recall is playing it mandate by ensuring that the process of improving the devices’ security runs smoothly.

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The Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) also issued an advisory covering the issue in detail.

What’s notable is that the process will not take place by medical and surgical procedures, which will make it even riskier due to the high-level sophistication involved.

Rather, a software update will be rolled out as supervised by FDA experts.

Of course, if the process involves the physical removal and replacement of the pacemakers from a patient, then it is evident that the lives of more patients will be at risk.

More so, this will see patients and insurance companies coughing out immense amounts of money running into millions of dollars to see the process undertaken.

For this reason, it is notable that only those with access to high financial means will be given priority over those who cannot afford the update.

These pacemakers are used by patients who have slow and irregular heart rates or those recovering from heart failure, among other conditions.

Six types of pacemakers are affected by the recall.

They’re all manufactured by Abbott, a health tech firm working in collaboration with St. Jude Medical to distribute the implantable devices, which are to be monitored remotely.

The FDA issued Abbott a warning letter earlier this year, addressing the security concerns.

A statement from Abbott said that no third party has gained unauthorized access to the any of the implantable devices.

However, due to technological advancements in the field of medicine, then hackers with access to the correct gadgets have the capacity to gain access to the device and cause it to malfunction in one way or another.

One wrong command could lead to more severe complications or the death of the patient since in real sense, the hacker has no clue of the patient’s medical complication.

What’s more, they most likely do not possess a dime of experience and knowledge in the medical field.

Now it is very crucial that all stakeholders come together to agree on the how to sort the matter.

FDA page on Facebook
FDA issued a warning earlier this year

The patients should be notified of the issue and further advised on the measures to take. It is therefore notable that the healthcare providers treat the matter with urgency, because of the hundreds of thousands of lives involved.

It is evident that the medical field is very broad. And with time, it is only logical to note that more fields will embrace technology to cater for the needs of their clients.

For this reason, it is important that all medical providers offer security to their patients—as of now and in the future.

Among the ways security in devices such as the pacemaker can be guaranteed is by investing in the infrastructure and expertise to ensure that as long as the initiative is in progress, then the infrastructure and personnel are adequate to monitor the platform.

So in the event of a cyberattack, which can occur in seconds, then there is a team to counter it.

Technically speaking, the teams involved will ensure the security of such implantable devices is constantly monitored.

Prospects and dynamics change over time, and thus is the need to keep up with the never-ending changes that occur from day to day in the digital world.

The flaws were initially discovered by a cybersecurity group, MedSec, which specializes in investigating discrepancies and vulnerabilities in devices used in the medical field.

The recall of the pacemakers is occurring for the second time since its inception.

Of course, this means that there might be more in the near future, depending on what security experts will determine.

This, therefore, means that the patients who have acquired these devices will have to face some sort of inconveniences from time to time.

Those to use the devices in the near future will have an advantage because of the fact that the latest version will have undergone more changes in terms of security.

However, they are not saved because they might have to comply with new security updates under the same supervision of the FDA.

Security firms, including MedSec, have continued to play a major role in preventing breaches of confidential information and the loss of funds.

And in the near future, more cybersecurity groups will work towards achieving the same in the medical field, just as MedSec has done in this scenario.



With the urge to know more about everything around us, I am an enthusiast researcher and writer with keen interest in expanding my knowledge in a bid to be well versed. Through writing, I express and share my feelings, ideas, and thoughts for like minded individuals.
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