The Fridley, Minn.-based medical device titan said the problem involves a vent membrane that’s susceptible to blockage during priming and fill-tubing. No pumps or glucose sensors are affected by the recall, Medtronic said, and infusion sets made since April 2017 use an updated vent membrane design.
“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,” diabetes chief medical officer Dr. Francine Kaufman said in prepared remarks. “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.”