The US Food and Drug Administration (FDA) has detected cybersecurity vulnerabilities in Medtronic’s implantable cardiac devices, clinic programmers and home monitors.

The issues were found in Conexus telemetry technology, which uses wireless radio frequency (RF) channels to enable Medtronic programmers and monitoring accessories to remotely transfer data from a patient’s cardiac device to a specific healthcare clinic.

Clinicians use the technology to display and print device information in real-time and programme implanted device settings.

Transmitted data is not encrypted and does not require authentication or authorisation. This could be exploited to enable an unauthorised individual to access and alter the devices.

The FDA’s alert covers cardiac implantable cardioverter defibrillators (ICD) or cardiac resynchronisation therapy defibrillators (CRT-D) but does not include pacemakers, cardiac resynchronisation pacemakers (CRT-P), CareLink Express monitors or the CareLink Encore Programmer.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
“The FDA recommends that healthcare providers and patients continue to use these devices as intended and follow device labelling.”

The US regulator advised healthcare providers and patients to continue using the devices while Medtronic works on new updates to mitigate the vulnerabilities.

A statement from the FDA read: “The FDA recommends that healthcare providers and patients continue to use these devices as intended and follow device labelling.

“Although the system’s overall design features help safeguard patients, Medtronic is developing updates to further mitigate these cybersecurity vulnerabilities.”

The agency added that no reports have been received regarding any harm to patients due to these cybersecurity issues.

In October last year, Medtronic disabled online updates for some of its CareLink and CareLink Encore programmers, as they were found to be vulnerable to cybersecurity attacks.

The programmers facilitate access to the company’s cardiac implantable electrophysiology devices (CIED), including pacemakers and defibrillators.