Medtronic recalls MiniMed insulin pumps as FDA warns about hacking risk

In its warning, the FDA noted that these devices pose the risk of someone nearby connecting wirelessly and then potentially hacking into the devices.

Posted: Jun 28, 2019 7:03 AM

(CNN) -- The US Food and Drug Administration issued a warning on Thursday about possible risk of hacking for some diabetes patients' insulin pumps.

Certain insulin pumps from Medtronic MiniMed have been recalled due to potential cybersecurity risks and it's recommended for people who use those insulin pumps to switch to different models, according to the FDA.

In its warning, the FDA noted that these devices pose the risk of someone nearby connecting wirelessly and then potentially hacking into the devices.

According to the FDA, the hacker could possibly change the pump's settings to either over-deliver insulin to a patient, which could lead to low blood sugar, or to stop insulin delivery altogether, which could lead to high blood sugar and a life-threatening complication called diabetic ketoacidosis.

Patients who have questions about replacing their pump can call Medtronic at 1-866-222-2584 or visit Medtronic's website.

The FDA noted that to minimize the potential risk of a cybersecurity attack while waiting on a replacement insulin pump, patients should:

  • Keep their insulin pumps and the devices that are connected to their pumps within their control at all times whenever possible.
  • Not share their pump serial number.
  • Be attentive to pump notifications, alarms and alerts.
  • Monitor their blood glucose levels closely and act appropriately.
  • Immediately cancel any unintended boluses.
  • Connect their Medtronic insulin pump to other Medtronic devices and software only.
  • Disconnect the USB device from their computers when they are not using it to download data from their pump.

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.

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