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FDA Issues Cybersecurity Alert on Medtronic Insulin Pumps

The U.S. Food and Drug Administration issued a warning on Tuesday regarding the vulnerability of some insulin pump devices made by Medtronic. The flaw makes the devices vulnerable to cyberattacks while presenting a possibility for hackers to interfere with insulin delivery by gaining access to the device.

The FDA, a U.S. government organization, has issued an advisory regarding the MiniMed 600 Series Insulin Pump System from Medtronic, which includes the MiniMed 630G and MiniMed 670G devices.

The Department of Health and Human Services safeguards the public's health by ensuring the efficacy, security, and safety of pharmaceuticals for use in humans and animals, medical devices, and vaccinations. The agency is in charge of regulating tobacco products as well as the safety and security of our country's food supply, cosmetics, nutritional supplements, and devices that emit electronic radiation.

The FDA pointed out that many parts, including the insulin pump, constant glucose monitoring (CGM) transmitter, blood glucose meter, and CareLink USB device, connect wirelessly. A technical malfunction could make it possible for someone to break in and trigger the pump to administer the patient with either too much or too little insulin.

The insulin pumps are offered by Medtronic's diabetes division, which generated $2.41 billion in sales in 2021, or 8% of the business's overall revenue.

In the aftermath of the security incident, Medtronic cautioned users about the dangers and offered suggestions, such as advising them to permanently disable the 'Remote Bolus' function on the pump, refrain from disclosing the serial number of the device to unauthorized individuals, and avoid connecting or linking devices in public.

The business warned that patients should never accept remote connection requests and other remote activities unless patients or support persons initiated them and should always detach the USB device from their laptop while it is not being used to download pump data.

Although medical equipment is frequently connected to the internet, hospital networks, and other devices, the FDA warned that these same characteristics may pose cybersecurity threats.

According to the FDA advisory, "Medical devices, like other computer systems, might be subject to security breaches, possibly affecting the device's safety and effectiveness."

The MiniMed 508 and Paradigm insulin pumps have security flaws that Medtronic is unable to fully fix with software updates or patches. The FDA said that it was working with Medtronic to identify, discuss, and anticipate the negative consequences of this risk.


CDSCO Warns Users and Providers against Potentially Hack-able Insulin Pumps!





The wireless communication between Medtronic’s Minimed insulin pumps and other remote controlled related devices like blood glucose meters. These have a high risk of being hacked.

Central Drug Standard Control Organization (CDSCO), the apex drug regulator issued an alert about a few of Medtronic PLC’s insulin pumps being hack-able in response to US FDA flagging the theme.

No complaints of the sort have been received so far from the market, but nonetheless it happens to be an essential issue that needs looking into and hence CDSCO alerted the medical professionals.

Due to the aforementioned alleged cyber-security issues, (nevertheless potential in nature) few of the insulin pumps from the Medtronic Minimed have been recalled.

The US drug regulator recommends people to swap their insulin pumps for different models due to the potential risks related with the communication between these pumps and other devices like glucose meters and CareLink USB device used with them.





An insulin pump is a medical device specifically designed to help  diabetics control their glucose levels. The device pumps insulin in the user’s body in continuous doses.

Every insulin pump from Medtronic’s Minimed has a serial number which according to CDSCO should never be shared.

Per the CDSCO’s alert, the insulin pumps which are susceptible to potential hacking, namely are, MiniMed Paradigm 715, 712, 722 and 754 with software versions 2.6A or lower.

According to sources, Medtronic is pre-emptive about informing the users, regulators and medical professionals about the potential cyber-hazards of the insulin pumps.

They are also readily working with researchers to aid the patients, users, doctors and stakeholders, find answers to any questions they may have.

Medtronic alluded to it that with the evolution of technology will “continue to collaborate with industry researchers and regulators and develop high quality therapies that will positively impact lives”.

The company also remarked that over the years many models of these insulin pumps have been launched where their quality has been focused upon with utmost seriousness and concern.