Medical device manufacturer Medtronic is back in the news but this time it’s not for their surgical staplers. The company has recalled some 322,000 MiniMed insulin pumps over concerns that they may be missing a critical component, or that those that have the component might actually be broken. The faulty or missing component can cause the pump to either over- or under-deliver insulin to the wearer and, as can be expected, the results can be catastrophic.
At least one death has already been tied to the faulty MiniMed pump, as have over 2,100 injuries. In addition, the company has records of over 26,000 complaints of device malfunction. As a result, the FDA considers the Medtronic MiniMed insulin pump recall a Class I recall. The Class I recall is reserved for those products whose continued use “may cause serious injuries or death.”
According to CBS News, the possibility of failure in the MiniMed pump was first publicly addressed by Medtronic back in November of 2019. Patients using the pump were asked to conduct a visual inspection of the pump themselves. Efforts focused on the pump’s retainer ring, and patients were advised to “stop using the pump if the reservoir doesn’t lock into the pump or if the retainer ring is loose, damaged or missing.”
Model 630G units from September 2016 to October 2019 and Model 670G units from June 2017 to August 2019 are covered by the recall, although any patient is encouraged to reach out to their doctor if they have concerns about the safety of their insulin pump.
This is the second recall of Medtronic insulin pumps in the past year. The first recall, occurring back in June, was tied to concerns that the device could be hacked via a wireless connection and set to perform in a way that could be harmful to the patient. The company also faced a recall in 2016 when it purchased medical device manufacturer HeartWare while the company was in the midst of addressing multiple safety letters and the eventual recall of its HVAD heart pump.