Insulin Over-Delivery Risk Prompts Medtronic to Issue Global Recall

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Medtronic is recalling specific lots of MiniMed infusion sets after learning of the risk of insulin overdelivery. The global, voluntary recall affects older insulin pump infusion sets that featured a vent membrane susceptible to blockage and consequently to overdelivery of insulin.

Patient field reports and a root cause analysis suggest overdelivery of insulin occurs shortly after an infusion set change if the vent membrane becomes blocked during the priming process. Medtronic thinks such blockages happen when

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