TUESDAY, Oct. 5, 2021 (HealthDay News) -- Medtronic has expanded a recall of its MiniMed 600 series insulin pumps to include more than 463,000 of the devices, nearly half of which the company says it has already replaced or upgraded for customers.
The pumps may deliver incorrect dosing of insulin and the recall has been identified by the U.S. Food and Drug Administration as a Class I recall -- the most serious type -- because use of the recalled devices may cause serious harm or death.
The pumps are used by people with type 1 diabetes to deliver insulin to manage their diabetes.
The recall was first announced in November 2019 for two models: Model 630G, which may be used by people 16 and older and was sold between September 2016 and February 2020, and Model 670G, which may be used by patients 7 and older and was sold from May 2015 to December 2020.
In an Oct. 5 update about the recall, Medtronic said it will now replace any MiniMed 600 series insulin pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.
Customers with questions about the recall can call Medtronic's 24-hour technical support line at 1-877-585-0166.
Medtronic previously alerted customers about missing or broken clear retainer ring of the MiniMed 630G and 670G insulin pumps.
The retainer ring helps 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 low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia).
Severe hyperglycemia and hypoglycemia can be life-threatening or may result in death.
Serious injuries and deaths have been reported among patients using MiniMed 600 series insulin pumps, but those incidents may not have been directly related to the damaged clear retainer rings that triggered the recall, according to a statement issued by the U.S. Food and Drug Administration.
Medtronic provided updated recommendations to customers:
"We have already replaced nearly half of the clear retainer ring pumps that were in use since November 2019 in the U.S.," the company said. "This includes fulfilling replacement requests associated with the November 2019 recall for clear retainer rings which were loose, damaged or missing. In addition, many patients who initially had a clear retainer ring pump have also upgraded to newer models over time or had a pump replaced at the direction of their physician, or for other reasons as well."
The American Diabetes Association has more on type 1 diabetes.
SOURCE: Medtronic; U.S. Food and Drug Administration news release, Oct. 5, 2021