Medtronic is recalling a series of insulin pumps that the FDA has identified as a Class I recall, the most serious type of recall.
On November 21, 2019 Medtronic notified affected customers and advised them to take precautions. In total, 322,005 devices were recalled in the U.S..
To date, the firm has received a total of 26,421 complaints in which the device malfunctioned. The firm is aware of 2,175 injuries and one death.
The recall is due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment. 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 following models are being recalled:
- MiniMed 600 Series Insulin Pumps
- Model 630G (MMT-1715) - all lots before October 2019
- Model 670G (MMT-1780) - all lots before August 2019
- Distribution Dates:
- Model 630G - September 2016 to October 2019
- Model 670G - June 2017 to August 2019
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.