Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment, according to the FDA.
If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death.
The firm has received a total of 26,421 complaints in which the device malfunctioned in this manner. The firm is aware of 2,175 injuries and 1 death.
Who may be affected
What to do
On November 21, 2019 Medtronic notified affected customers and advised them to:
Customers who have questions or need additional information or support about this recall should call the 24-hour Medtronic Technical Support at 877-585-0166.