Medtronic Urgent Recall of MiniMed Insulin Infusion Sets

Washington, DC: Medtronic in conjunction with the US Food and Drug Administration, has issued an urgent, global recall of its defective Medtronic MiniMed Paradigm Insulin Infusion Sets following reports of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets.

In a statement posted on its website, Medtronic says that it “has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue.”

Medtronic states that its own investigation into the defect shows that he over-delivery of insulin “can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly.”

The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.

The FDA states on its website that Medtronic sent an Urgent Medical Device Safety Notification letter dated June 10, 2013, to all affected consignees. The letter identified the product and notified healthcare professionals of the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. The letter stated that it applies to all Medtronic infusion sets designed for use with Medtronic Paradigm family infusion pumps.

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Published on Sep-12-17