Medtronic recalls MiniMed insulin pumps due to shorter-than-expected battery life
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Key takeaways:
- All Medtronic MiniMed 600 and 700 series insulin pumps have been recalled due to an increased risk for short battery life.
- Shortened battery life could cause insulin therapy to stop and lead to adverse events.
Medtronic has issued an urgent medical device correction letter warning users of the MiniMed 600 and 700 series of insulin pumps of an increased risk for shorter-than-expected battery life, according to an FDA press release.
The FDA categorized the recall as class I, the most serious kind.
On Oct. 4, Medtronic notified users of the 630G, 670G, 770G and 780G insulin pumps of an increased risk for shorter-than-expected battery life and less time until the pump shuts down following a low battery alert. According to the release, battery life can be impacted for users who dropped, bumped or experienced another physical impact with their insulin pump.
A decrease in battery life could lead to insulin delivery stopping sooner than expected and may cause serious adverse events, including hyperglycemia, diabetic ketoacidosis and death, according to the release. From January 2023 to September 2024, Medtronic received 170 reports of hyperglycemia and 11 reports of DKA related to battery life issues. No deaths have been reported in relation to shortened battery life.
The FDA stated in its release that on July 31, Medtronic issued a safety alert to MiniMed users to follow built-in alerts and alarms regarding battery status on their insulin pump, and to contact the company if they observe changes in battery life. The company later followed up with the urgent medical device correction letter on Oct. 4.
According to the urgent medical device correction letter, MiniMed users are asked to carry an extra set of AA lithium or alkaline batteries, or fully-charged nickel–metal hydride batteries in case a change is needed. Users should replace batteries as soon as they receive a “low battery pump” alert and should not wait for later alerts. Insulin delivery stops once a “replace battery now” alarm occurs on an insulin pump. Users should have backup insulin available in their emergency kit in case their pump stops operating.
MiniMed users can call Medtronic’s 24-hour technical support team at 1-800-378-2292 if they experience any issues regarding battery life to determine whether they need a replacement pump.
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