medtronicThe company, which develops, manufactures and sells medical devices, has announced a voluntary recall of MiniMed 600 Series or 700 Series Insulin Pumps due to the potential for reduced battery life in the pumps.
The company will begin field action on July 31, encouraging customers around the world to monitor the built-in alarms and alerts on their MiniMed pumps to track battery health and notify customers if they notice a change in their pump’s battery life. notified to contact.
Medtronic has received complaints from customers that battery life is reduced over time if the pump is bumped, dropped, or subjected to any physical impact, immediately after a fall, or due to internal damage to the device. He said he has started analyzing the pump’s battery life. electrical parts.
“This electrical issue may also cause a battery alert when the battery level is lower than stated in the user guide. This could cause the pump to stop delivering insulin much earlier than normally expected. “This can lead to health risks such as hyperglycemia and diabetic ketoacidosis (DKA), potentially requiring medical intervention,” the company said in a statement.
“Most recently, Medtronic announced that from January 2023 to September 2024 in the United States, there have been 170 reports of hyperglycemia greater than 400 mg/dL and 11 reports of diabetic ketoacidosis that may be related to this issue. I received it.”
The FDA classified this issue as a “memorable class,” which is the most serious type of recall. This means that use of the product may very well result in serious injury or death.
The company says that the pump will continue to generate battery warnings and alarms, but that they will “as long as there is normal battery life remaining before the battery needs to be replaced to avoid the pump stopping delivering insulin.” Said it would not be provided.
Medtronic recommends that users replace batteries as soon as the “low battery pump” alarm sounds, carry a spare set of batteries in case they need to be replaced sooner than expected, and provide backup therapy in case they are needed. He said it was necessary to prepare.
The Dublin-based company says that users who experience a significant decrease in battery life, whether their pump has been dropped or subjected to other physical shock, can contact the company to determine whether they need a replacement pump. He said he needed to contact them.