SPRINGFIELD, Mo. — The Food and Drug Administration (FDA) has issued a class I recall on certain types of Medtronic insulin pumps. A class I recall means the devices could cause serious injuries or death.
The recalled product is Model 630G and 670G of the MiniMed 600 Series Insulin Pumps. Replacement pumps will be given to each person no matter the warranty or amount of damage done to the pump.
The recall is due to the retainer ring on each pump that helps lock the insulin cartridge in place. If the cartridge is not locked firmly into place, the device could deliver a higher or lower amount of insulin than intended.
Too much insulin can cause hypoglycemia while not enough can cause hyperglycemia.
According to the FDA, Serious injuries and deaths have been reported. These individuals were using the recalled insulin pumps, but the FDA said these incidents may not have been directly related to the damaged clear retainer rings.
Anyone with one of these insulin pumps is asked to check if the device has a clear retainer ring by checking the serial number online. If the pump has a clear retainer ring, call Medtronic Technical Support at 877-585-0166.
These recalled pumps can only be worn if the retainer ring is not loose, damaged, or broken. If the ring is damaged, the FDA says to switch to shots to take insulin until the replacement pump arrives.