Medtronic has initiated a worldwide voluntary recall of specific lots of MiniMed infusion sets used with all models of Medtronic insulin pumps. The company said it has 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,” the company said in a news release.
The currently manufactured infusion sets, available 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 recommends that customers use only infusion sets made with the new and enhanced component, called the membrane, starting with their next set change.
The company asks that customers check online to determine whether they have infusion sets that have been recalled.
“Because this recall applies to all versions of infusion sets that are used with Medtronic insulin pumps, to publish a list of specific lot numbers would be unwieldy,” Pamela Reese, Medtronic senior manager for communications, told Medscape Medical News. “This is why we designed the [online] lot look-up tool. When using this lot look-up, customers will be able to automatically process the exchange for new sets as well.
“It is difficult to predict how many unused, recalled infusion sets are in customer hands that will need an exchange. Most customers likely have a mixture of recalled and new infusion sets in their possession,” added Reese.
The company said it will work with patients to ensure that 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. 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,” Francine Kaufman, MD, chief medical officer of the Diabetes Group at Medtronic, said in the release.
Medtronic has alerted the US Food and Drug Administration (FDA) and other regulatory bodies around the world. The recall notification letter is available online.
Adverse events or side effects related to the use of these products should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
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