Health Care

Insulin Pumps Recalled Due To Concerns They Could Be Hacked

Insulin Pumps Recalled Due To Concerns They Could Be Hacked”

The specific recalled pumps are Medtronic's MiniMed 508 insulin pump and MiniMed Paradigm series.

Medtronic announced the recall of thousands of MiniMed and Paradigm insulin pumps on June 27, revealing the discovery of a 'potential cybersecurity risk.' According to the company, these insulin pump models featuring wireless RF connectivity can possibly be accessed by hackers who have the right skills and equipment. Around 4,000 patients in the USA may be using these recalled pumps.

If this happens, the hacker may be able to wirelessly change the settings and the amount of insulin delivered to the individual using the pump. It could also cause too little insulin to be delivered, and a diabetes patient could suffer from hyperglycemia and diabetic ketoacidosis.

"While we are not aware of patients who may have been harmed by this particular cybersecurity vulnerability, the risk of patient harm, if such a vulnerability were left unaddressed, is significant", she added.

It's interesting to note that numerous vulnerable Medtronic MiniMed insulin pumps are highly prized by diabetes sufferers because they have a security flaw that allows them to modify the firmware.

Health Canada has not yet replied to a request for more information, but as of Friday afternoon there were no safety notifications on its website about the Medtronic insulin pumps.

In March, the FDA warned about cybersecurity risks in Medtronic's implantable cardiac devices and telemetry systems.

MiniMed 508 and Paradigm devices may be vulnerable to hacking. FDA has yet to confirm a report of patient harm related to this recall.

Pamela Reese, a communication director at Medtronic, said that the devices listed in the FDA safety notification "were first brought to market in 2012 or earlier" and that most Medtronic costumers are not now using them.

In the United States, Medtronic has identified about 4,000 patients who are potentially using insulin pumps that are vulnerable to this issue and the company is working with distributor partners to identify additional patients potentially using these pumps, according to the FDA.

Affected models include all versions o the MiniMed 508, MiniMed Paradigm 511, MiniMed Paradigm512/712, MiniMed Paradigm 515/715, MiniMed Paradigm 522/722 and MiniMed Paradigm 522K/722K. Medtronic is providing alternative insulin pumps to patients with enhanced built-in cybersecurity capabilities. "As technologies evolve, we will continue to collaborate with industry researchers and regulators to improve device security approaches and develop high-quality therapies that positively impact lives".

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