Medtronic has recalled its 600 series of MiniMed insulin pumps due to a missing or broken retainer ring, which helps to lock the insulin cartridge in place in the pump’s reservoir compartment, according to the FDA.
The FDA stated that if the insulin cartridge is not locked firmly in place, under- or over-delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. The agency identified the issue as a class I recall, the most serious type of recall, which indicates that use of such devices may cause serious injuries or death.
The recall includes the MiniMed 630G (all lots before October 2019) and the MiniMed 670G (all lots before August 2019). The FDA stated that the company has received 26,421 complaints that the device malfunctioned in the described manner.
“The firm is aware of 2,175 injuries and one death,” the FDA stated on its website.
On Nov. 21, Medtronic notified affected customers and advised them to examine the retainer ring of their pump and stop using 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.
Medtronic has recalled its 600 series of MiniMed insulin pumps due to a missing or broken retainer ring, which helps to lock the insulin cartridge in place in the pump’s reservoir compartment.
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“If you stop using the pump, you should follow your doctor’s recommendations and perform manual insulin injections,” the FDA stated, adding that people may continue using the pump if the reservoir locks in place correctly.
If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.
As Healio previously reported, Medtronic in June recalled its MiniMed 508 and MiniMed Paradigm insulin pumps due to cybersecurity vulnerabilities identified in the device. The potential risks are related to the wireless communication between Medtronic’s MiniMed insulin pumps and other devices such as blood glucose meters, continuous glucose monitoring systems, the remote controller and CareLink USB device used with these pumps. In an FDA press release at the time, the agency recommended that patients using the recalled models switch to pumps that are “better equipped to protect against potential risks.”
Customers or health care providers who have questions or need additional information or support about the recall should contact 24-hour Medtronic technical support at 877-585-0166. – by Regina Schaffer