Medtronic, which develops, manufactures and sells medical remedy gadgets, has issued a voluntary recall of its MiniMed 600 collection or 700 collection insulin pumps as a result of pump’s probably shortened battery life.
The corporate issued a discipline motion, beginning on July 31, notifying prospects globally that they need to monitor their MiniMed pump’s built-in alarms and alerts to maintain observe of battery standing and get in touch with the corporate in the event that they discover adjustments within the pump’s battery life.
Medtronic stated it started analyzing its pump’s battery life after receiving buyer complaints that if the pump was bumped, dropped or had any bodily affect even as soon as, they skilled a shortened battery life both instantly after the drop or over time as a consequence of harm to the gadget’s inner electrical parts.
“This electrical problem additionally causes battery alerts to happen when much less battery life stays than the Person Information states. This will likely end result within the pump stopping insulin supply considerably prior to normally anticipated and will result in well being dangers like hyperglycemia or diabetic ketoacidosis (DKA), probably requiring medical intervention,” the corporate stated in a press release.
“Most not too long ago, Medtronic has obtained 170 reviews of hyperglycemia >400 mg/dL and 11 reviews of diabetic ketoacidosis from January 2023 to September 2024 within the U.S. probably associated to this problem.”
The FDA categorized the difficulty as a category I recall, which is essentially the most severe sort of recall, that means there’s a cheap probability that utilizing the product might end in severe harm or demise.
The corporate stated the pump would nonetheless generate battery alerts and alarms, however they might not be delivered “with the standard quantity of battery life remaining earlier than the battery should be changed to keep away from the pump stopping insulin supply.”
Medtronic stated customers ought to change the battery as quickly because the “Low Battery Pump” alarm sounds, carry an additional set of batteries ought to they have to be changed prior to anticipated, and have a backup remedy in case it’s wanted.
The Dublin-based firm stated no matter whether or not the pump has skilled a drop or one other bodily affect, customers who expertise a major lower in battery life ought to contact the corporate to find out if a substitute pump is required.
