Medtronic announced Sept. 11 that it 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 for a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. According to recent reports from patients and root-cause analysis, 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 and may cause hypoglycemia.
Current manufactured infusion sets include a design update of this component that Medtronic believes reduces the risk of insulin over-delivery after an infusion set change. Medtronic said they are working with patients on recalled infusion sets with the discontinued component to replace the recalled sets 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,” said Francine Kaufman, MD, chief medical officer of the Diabetes Group at Medtronic in a press release. “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.”
Read the full press release on the Food and Drug Administration’s website.