Medtronic voluntarily recalls insulin pumps due to risk of shortened battery life

By Ciara Linnane

Company says a single drop, bump, or physical impact can affect batteries by damaging internal electronics

Medtronic Plc announced a voluntary recall Friday of certain insulin pumps after customers said a single drop, bump, or physical impact could shorten their battery life.

The Galway, Ireland-based medical device maker (MDT) said it issued a field action starting July 31, notifying global customers of its MiniMed 600 series or 700 series insulin pumps to follow built-in alerts and alarms for battery status and inform the company if they noticed changes in battery life of the pump.

Insulin pumps are used by diabetics to monitor and deliver insulin through the day, avoiding the need for painful injections and keeping blood sugar stable.

The company first started to investigate the issue after receiving reports from customers that if pumps were dropped, bumped or experienced physical impact even once it could lead to shortened battery life due to damage to internal electronic components.

"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," said Medtronic.

The company has now received 170 reports of hyperglycemia and 11 reports of DKA in the period stretching from January of 2023 to September 2024 in the U.S., potentially relating to the issue. The Food and Drug Administration has classified the action as a class I recall.

In its latest notification, the company is cautioning customers that even a dingle drop of the pump could shorten its battery life, either immediately after the incident, or over time. The issue will persist even if the battery is replaced.

The pump will still generate alerts, but they may not be delivered with the usual amount of battery life remaining before it requires replacement to avoid it stopping insulin delivery.

"Be prepared to replace the battery as soon as the "Low Battery Pump" alarm sounds," the company said.

It further advised users to always carry an extra set of AA lithium or alkaline batteries, or fully charged NiMH batteries in case they need to be replaced sooner than expected.

Users who notice any shorter battery life, even if they have not dropped the pump, should contact their local Medtronic team to see if a replacement is needed.

"Our team is here 24 hours a day, 7 days a week to help if you experience battery depletion or any other issue with your pump," Medtronic Chief Medical Officer Robert Vigersky said in prepared remarks.

"Patient safety is our priority, as is continuity of therapy, which is why we made the decision to voluntarily notify patients and will replace pumps when needed."

The stock was flat premarket but has gained 6.5% in the year to date, while the S&P 500 has gained 19.5%.

-Ciara Linnane

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10-04-24 1000ET

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