The Medtronic Mini-Med 600 series pumps have been recalled due to malfunctions.
The makers of the pump say the devices are giving incorrect dosages because of a retainer ring that doesn't properly lock. Failing to keep the lock the insulin cartridge could cause hypoglycemia or hyperglycemia. The recall is classified as a Class 1, the most serious type of recall.
The pumps are used by people with Type 1 diabetes to deliver insulin for management of the disease, the FDA said.
Medtronic began directly notifying patients and doctors on November 21, 2019, that there were potential problems with the pumps. Medtronic received 26, 421 complaints where the device malfunctioned and is aware of 2,175 injuries in addition to the death. The resulting problems could lead to loss of consciousness, seizures or death.
The pumps are being recalled because a retainer ring is either missing or broken.
If the reservoir locks in place correctly, customers may continue to use their pump, Medtronic officials said.
If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.
More than 300,000 devices are included in the recall.
If it's loose, damaged or just not there, contact Medtronic at 877-585-0166 and stop using the pump.