Medtronic is facing a Class I recall from FDA for the MiniMed Insulin Pump. The recall was issued on February 12 and one death and 2,175 injuries are connected to the technology. Medtronic told MD+DI in an email it proactively notified customers in November of 2019 about a potential issue with MiniMed 600 series insulin pumps.
The Dublin-based company’s pumps faced the recall because of a missing or broken retainer ring that helps lock the insulin cartridge into place. Medtronic said if the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.
The firm said If a customer’s reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, that it is asking customers to discontinue using the insulin pump and contact Medtronic 24-Hour Technical Support.
In an email sent from Medtronic to MD+DI, the medtech giant said it “will replace pumps that have damage to the retainer ring and advises customers to examine their pump retainer ring during each infusion set and reservoir change to ensure the reservoir locks in place. Based on our analysis of damaged retainer rings from past insulin pumps, we made improvements to the pump design to better withstand the accidental dropping or bumping of a pump on hard surfaces.”
The recall includes Medtronic’s MiniMed 670g, an insulin pump dubbed the artificial pancreas. The technology was a gamechanger in the diabetes market and received a nod from FDA in 2016.