Medtronic, which develops, manufactures and sells medical therapy devices, has issued a voluntary recall of its MiniMed 600 series or 700 series insulin pumps due to the pump's potentially shortened battery life.
The company issued a field action, starting on July 31, notifying customers globally that they should monitor their MiniMed pump's built-in alarms and alerts to keep track of battery status and contact the company if they notice changes in the pump's battery life.
Medtronic said it began analyzing its pump's battery life after receiving customer complaints that if the pump was bumped, dropped or had any physical impact even once, they experienced a shortened battery life either immediately after the drop or over time due to damage to the device's internal electrical components.
"This electrical issue also causes battery alerts to occur when less battery life remains than the User Guide states. This may result in the pump stopping insulin delivery significantly sooner than usually expected and could lead to health risks like hyperglycemia or diabetic ketoacidosis (DKA), potentially requiring medical intervention," the company said in a statement.
"Most recently, Medtronic has received 170 reports of hyperglycemia >400 mg/dL and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the U.S. potentially related to this issue."
The FDA classified the issue as a class I recall, which is the most serious type of recall, meaning there is a reasonable chance that using the product could result in serious injury or death.
The company said the pump would still generate battery alerts and alarms, but they would not be delivered "with the usual amount of battery life remaining before the battery must be replaced to avoid the pump stopping insulin delivery."
Medtronic said users should replace the battery as soon as the "Low Battery Pump" alarm sounds, carry an extra set of batteries should they need to be replaced sooner than expected, and have a backup therapy in case it is needed.
The Dublin-based company said regardless of whether the pump has experienced a drop or another physical impact, users who experience a significant decrease in battery life should contact the company to determine if a replacement pump is needed.
English (US) · 