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Medtronic recalls insulin pump infusion sets
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Medtronic initiated a worldwide voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps due to a discontinued component, the company announced in a press release.
Through recent field reports from patients and root cause analysis, the company determined that 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.
Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component that the company believes reduces the risk for insulin over-delivery after an infusion set change. Medtronic 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.
“Our priority is to work with our patients to mitigate risk to patient safety,” Francine Kaufman, MD, chief medical officer of the diabetes group at Medtronic, said in the statement. “While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients. Our Medtronic diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process."
Medtronic recommends that customers use only infusion sets made with the new and enhanced component, the membrane, starting with their next set change. The company also reminded customers to follow the Key Steps document included with the recall notification letter regarding the priming/fill-tubing process — especially if a person has only recalled infusion sets.
Customers in the United States can determine whether they have recalled infusion sets by visiting www.checklots.medtronicdiabetes.com. A copy of the U.S. recall notification letter is available at www.medtronicdiabetes.com/notice7.