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.
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Medtronic has announced a safety issue in its popular MiniMed 600 series of insulin pumps. The devices may under- or over-deliver insulin if a ring component of the device cracks or breaks, potentially causing serious health issues. The company says the issue doesn’t amount to a recall, however.
The hybrid closed-loop automated insulin delivery system, the first closed-loop system approved anywhere in the world, automatically monitors glucose and provides appropriate basal insulin doses in people with type 1 diabetes.
The US FDA has announced a high-risk class I recall on two makes of coronary dilation catheters made by Abbott Vascular because a manufacturing issue could lead to difficulties deflating the balloon. The catheters have been linked to 13 complaints and one death.