Insulin Pump Recall Leads To FDA Warning Letter For Medtronic
The missive reflects quality systems issues at the Northridge, CA headquarters of Medtronic’s diabetes division. Analysts are split on what the warning letter’s long-term impact may be.
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The US FDA released four device-related warning letters in April, involving alleged regulatory violations from Abbott, North American Diagnostics, Medivance and Synovo. The agency also closed out a 2021 Medtronic warning letter.
Medtech Insight spoke to the president of Medtronic’s diabetes business, Que Dallara, as well as two of the company’s medical affairs directors, about the company’s recently published data, and the timeline for the US launch of its 780G system.
Medtronic’s MiniMed series insulin pumps could allow unauthorized hackers to change the amount of insulin delivered to a patient, the FDA says.