Medtronic is warning more patients who use some of the company's older insulin pumps about a cybersecurity vulnerability that could allow hackers to harm patients by changing drug-delivery settings.
Medtronic expands recall on 'remote controller' used with old insulin pumps
Medical device maker says 31,300 users of older insulin pumps should disable a remote control feature that's vulnerable to hacking.
October 8, 2021 at 7:33PM
Medtronic, which has operational headquarters in Fridley, previously issued a warning in 2019 about the issue, which was thought at the time to apply to at least 4,000 patients. The updated recall now applies to some 31,310 devices and continues to be considered by the Food and Drug Administration (FDA) as a "Class I" recall, which is the most serious type.
The insulin pumps in question were introduced to the market before 2013.
"To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks," the federal agency said this week in its updated recall notice.
In patient notifications the company began issuing Tuesday, Medtronic said further review determined the potential risks of using the remote controller outweigh the benefits.
As a result, patients "should immediately stop using and disconnect the remote controller, disable the remote feature, and return the remote controller to Medtronic," the company said.
"Medtronic first communicated this recall to some users in August 2018," Medtronic said in its notice to patients. "At that time, only users whose pumps were under warranty received the recall notification. Medtronic is now expanding the notification to all users who Medtronic believes may still be using the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps and have purchased a remote controller."
People with diabetes use pumps to deliver insulin for management of their condition. The MiniMed systems included an optional remote controller to communicate wirelessly with the pump about the amount to be delivered.
"The remote controllers impacted by this issue are older models that use previous-generation technology," the FDA said in its recall notice. "As of July 2018, Medtronic is no longer manufacturing or distributing these remote controllers."
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