Medtronic is recalling about 322,000 of its MiniMed insulin pumps due to a malfunction that has led to more than 2,000 injuries and one death, the Food and Drug Administration (FDA) announced Wednesday.
The FDA says the malfunction involves a missing or broken retainer ring, which helps lock insulin cartridges into place in the reservoir compartment of the affected pumps.
“If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia,” wrote the FDA. “Severe hyperglycemia can result in a loss of consciousness, seizure, and death.”
The FDA has identified this as a Class I recall, the most serious type of recall.
“Use of these devices may cause serious injuries or death,” wrote the FDA.
The following MiniMed 600 Series insulin pumps are subject to the recall:
· Model 630G (MMT-1715) - all lots before October 2019
· Model 670G (MMT-1780) - all lots before August 2019
The Model 630G product was distributed between September 2016 and October 2019, while the Model 670G product was distributed between June 2017 and August 2019, according to the FDA.
The insulin pumps are used by people with Type 1 diabetes to deliver insulin to manage the disease, which causes your glucose levels to fluctuate.
What customers should do
Medtronic is advising customers to examine the retainer ring of their pump. If the reservoir doesn’t lock into the pump or if the retainer ring is loose, damaged or missing, customers should stop using the pump and contact Medtronic for a replacement. If the reservoir locks in place correctly, Medtronic says to continue using the pump.
If the pump is dropped by accident, Medtronic says to check the product and retainer ring for damage. If it’s damaged, stop using it.
Lastly, Medtronic says to check the pump retainer ring to verify that the reservoir is locked correctly at every set change.
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.