Medtronic Infusion Set Recall
Today, Medtronic announced a recall specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors.
What do I need to do?
Check to see if your infusion sets are impacted by this recall here, and further instructions for next steps and replacement can be found here.
What is being recalled?
A component called 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 current manufactured infusion sets, available since April 2017, include a design update of this component which the company believes reduces the risk of 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. 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, M.D., chief medical officer of the Diabetes Group at Medtronic. “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 from Medtronic.
If you are in the U.S. and have experienced an issue with the use of a Medtronic infusion set, please report it to the 24-hour helpline at +1-800-204-7616.
