Medtronic has recalled two insulin pumps after more than 2,000 injuries and one death.
Medtronic recalled all Model 630G pumps from before October 2019 and all Model 670G pumps from before August 2019, according to the FDA.
All lots of MiniMed Model 630G from before October 2019 and all lots of MiniMed Model 670G from before August 2019.
The pumps are used by people with Type 1 diabetes to deliver insulin for management of the disease, the FDA said. This model is used by people 14 and older. Besides people with diabetes who use the pump, this may affect health care providers who treat people with diabetes using this pump.
On Thursday, the FDA issued a statement warning that the MiniMed 600 Series devices are known to have a missing or broken retainer ring, which helps keep the insulin cartridge locked in the pump's reservoir compartment. If the cartidge is not locked firmly into place, under or over delivery of insulin may happen, which could result in hypoglycemia or hyperglycemia. The resulting problems could lead to loss of consciousness, seizures or death.
So far, the federal agency has received over 26,420 complaints related to this malfunction.
Stop use of the pump and contact Medtronic for a replacement pump if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing.
The Food and Drug Administration announced the recall Wednesday, but Medtronic began communicating with customers in November.