Medtronic MiniMed Insulin Pump Recall Over Battery Failure Risks

MiniMed insulin pumps have a history of problems that have led to numerous recalls over the last decade, following reports of over or under delivery of insulin.

Nearly 25,000 Medtronic MiniMed insulin pumps are being recalled because they could have shorter battery lives after suffering impacts, such as being dropped, which could result in life-threatening failures to adequately supply the body with insulin when needed.

The MiniMed 630G and 700G insulin pump recall was announced by the U.S. Food and Drug Administration (FDA) on October 3, with a class I designation, meaning the agency believes the battery problems with the MiniMed insulin pumps could lead to serious injuries or death.

MiniMed Insulin Pump Problems

The Medtronic MiniMed pumps are small, computerized devices that deliver insulin to diabetic patients throughout the day via a catheter that is implanted under the skin. They are wirelessly connected to both a monitoring system to track glucose levels, as well as a remote controller designed to communicate with the pump and deliver a specific amount of insulin.

Due to serious design problems, Medtronic’s MiniMed 600 series models and the MiniMed 780G models were subject to a number of recalls between 2009 and 2020, after more than 26,000 complaints involving the insulin pumps were identified.

As a result of the manufacturers’ failure to properly design and test these critical drug delivery pumps, a number of Medtronic MiniMed pump lawsuits have been pursued on behalf of patients who suffered serious injury or death when they received too much or too little insulin. However, since there is no consolidated pretrial proceeding established in the federal court system, the claims are pending before various different U.S. District Judges nationwide.

According to the new recall notice, MiniMed pumps that have experienced a physical impact may have damaged internal electronics, which could reduce battery life, requiring more frequent battery changes.

“Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly,” the recall notice states. “Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur.”

The FDA warns that depleted batteries could result in power loss and failure to deliver insulin, which could result in hyperglycemia or diabetic ketoacidosis.

The recall affects 24,595 Medtronic MiniMed 630G and 700G insulin pumps, including all serial numbers. The devices have been sold throughout the U.S. For more information on the specific units affected, visit the FDA’s recall notice linked above.

Medtronic initially sent out a safety alert to its customers in late July, making them aware of the problem. The company instructed users to always pay attention to the device’s alarms and alerts, when to replace the battery, to keep extra batteries available and to contact Technical Support at 800-646-4633 with any questions.