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Diabetes Infusion Sets by Medtronic

Recall – Vent Membrane May be Susceptible to Being Blocked by Fluid

See the FDA Safety Alert

ISSUE: Medtronic is informing patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia.

By | November 8th, 2017|alerts|0 Comments

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