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.
US FDA Deems MiniMed Safety Issues Class I Recall
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.
