Medtronic MiniMed recalled 12,126 glucose monitoring devices on October 21, 2025. A software error can lead to incorrect glucose readings, risking hypoglycemia or hyperglycemia. Affected consumers should stop using the device immediately and contact their healthcare provider.
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic MiniMed, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the CareLink Clinic, REF: MMT-7350, with software versions 4.2B. It was distributed worldwide, including all U.S. states and multiple international markets.
A software error can cause incorrect data on the 24-hour Sensor Glucose Overview Graph. Therapy decisions based on this data may result in serious health risks, including hypoglycemia or hyperglycemia.
There are no specific incident or injury reports mentioned. However, the potential for severe health consequences exists due to the nature of the software error.
Patients and healthcare providers must stop using the device immediately. Follow recall instructions from the manufacturer. Contact Medtronic MiniMed, Inc. or your healthcare provider for further guidance.
For further assistance, contact Medtronic MiniMed, Inc. Visit the FDA website for additional recall details.
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