Insulin Pump Recall Leads To FDA Warning Letter For Medtronic

 
• By Elizabeth Orr

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.

Medtronic sign.
• Source: Shutterstock

A recall of insulin pumps manufactured by device giant Medtronic plc has brought additional trouble to the company, which on 15 December announced that it has received a warning letter from the US Food and Drug Administration tied to a recent inspection of the firm’s diabetes business headquarters.

The inspection of the Northridge, CA, facility concluded in July 2021 and was related to expanded recalls of the MiniMed 600 series insulin infusion pump, and a remote controller device for MiniMed 508 and Paradigm pumps

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