The US Food and Drug Administration (FDA) has issued a Class I tag to Medtronic’s recall of its MiniMed insulin pumps after the manufacturer noticed battery life issues earlier this year.
Medtronic sent a safety alert to customers back in July this year, notifying customers of its diabetes device to follow built-in alerts and alarms for battery status. The company has now sent an updated letter detailing how the shortened pump battery life arises.
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The issue affects the MiniMed 600 series and 700 series pump systems – which supplies a flow of insulin to diabetes patients based on recordings from an attached continuous glucose monitor (CGM).
Around 785,000 systems are implicated in October Class I recall, as per the FDA’s device recalls database.
Shares in the NYSE-listed company were down 1.5% at market close on 3 October compared to a pre-announcement market close the day before. Medtronic has a market cap of $112.6bn.
After a “comprehensive analysis”, Medtronic found that dropping, bumping, or hits to the device could result in shortened battery life. This is due to the internal electrical components being damaged, according to the company.
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By GlobalData“Even a single drop could result in reduced battery life, either immediately after the drop, or over time, and will continue to affect the pump even after replacing the battery,” Medtronic said in the alert.
Whilst affected pumps may signal a certain amount of battery life is remaining, the true amount may be significantly shorter. This can result in patients not receiving insulin delivery after ‘replace battery alarm’ appears. Extended time without insulin delivery can lead to health risks such as hyperglycaemia or diabetic ketoacidosis (DKA).
Medtronic has received 170 reports of hyperglycaemia and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the US, which it says is potentially related to this issue.
Medtronic has asked patients to ensure spare batteries are always at hand in case the device’s batteries need replacing sooner than expected, along with paying attention to the alerts and alarms displayed on the pump. Users are also advised to have a back-up therapy set up.
Medtronic’s chief medical officer Robert Vigersky said: ”Medtronic began proactively notifying impacted pump users in July because of the high priority we place on patient safety and understand the important role of pumps in the care and management of diabetes.”
“Our team is here 24 hours a day, seven days a week to help if you experience battery depletion or any other issue with your pump. 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 diabetes device space was rocked by another high-profile recall recently, after Abbott’s popular FreeStyle Libre 3 CGM was found to have issues with its sensors. The FDA also classed that recall as Class I.
