Cybersecurity Risk with Medtronic MiniMed Insulin Pumps Prompts FDA Warning and Medtronic Recall

By MedTech Intelligence Staff

The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.

Register for the Medical Device Cybersecurity: Legacy Device Remediation, Compensating Controls, &  End-of-Life Conference | September 26–27, 2019 | Attend in person or virtuallyYesterday FDA issued a safety communication alert to patients and healthcare providers about the Medtronic MiniMed insulin pump after the agency was made aware of potential cybersecurity vulnerabilities. The problem is that an unauthorized person could wirelessly connect to the insulin pump and then change its settings to either over-deliver insulin or stop insulin delivery, both of which can lead to adverse health consequences.

Medtronic cannot make updates to its MiniMed 508 and Paradigm insulin pump models that address the risks so the company is recalling several of the models and is giving patients alternative insulin pumps.

A full list of the recalled pumps is available on FDA’s website.

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