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US FDA Deems MiniMed Safety Issues Class I Recall

 
• By Elizabeth Orr

Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.

detailed illustration of a compass with Recall text, eps10 vector

A mechanical issue that could lead to dangerous over- and under-doses of insulin for patients using Medtronic’s MiniMed 600 series of insulin pumps qualifies as a high-risk class I recall, the US Food and Drug Administration said on 12 February.

The problem originates with a retainer ring used to lock the insulin cartridge into place in the pump’s reservoir component....

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