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Medtronic recall specific lots of infusion sets with all models of Medtronic insulin pumps
September 11th 2017
Medtronic has started to inform 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 discontinued component in these infusion sets and does not include insulin pumps or glucose sensors.
The 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 can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycaemia.
Currently manufactured infusion sets, available from April 2017, include a design update of this component which the company believes reduces the above risk.
The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost. Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue and will continue working directly with government and regulatory authorities on this global voluntary recall.
Medtronic recommends that customers use only infusion sets made with the new and enhanced component, the membrane, starting with their next set change.
Customers in the United States can determine if they have recalled infusion sets by visiting https://checklots.medtronicdiabetes.com.
Customers in Europe, Middle East and Africa (EMEA region) can determine if they have recalled infusion sets by visiting www.mmc.medtronic-diabetes.com/look.
Medtronic also advise that patients can always consult the advice of their healthcare professional regarding their medical treatment.