Medtronic MiniMed recalled 116,645 MiniMed 640G insulin pumps worldwide, including the United States. The devices can deliver too much or too little insulin when the pump height changes relative to the infusion site due to gravity-driven pressure shifts. Stop using the pump immediately and contact Medtronic MiniMed or your healthcare provider for guidance.
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
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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Medtronic MiniMed insulin pumps are used by people with diabetes to continuously deliver insulin. These devices are part of a medical device ecosystem that combines hardware with monitoring and software to manage blood sugar.
The infusion pump can mis-dose insulin when its height relative to the infusion site changes. This is due to gravity-driven pressure changes affecting how insulin is delivered.
This recall is not described as part of a broader industry pattern in the provided data.
Patients could experience severe blood sugar events requiring emergency care. The recall emphasizes immediate cessation of use and consultation with a clinician.
Recall details and instructions are available on the FDA enforcement page and Medtronic’s recall communications.
Refunds or replacements are typically processed within weeks after verification, depending on the manufacturer's procedures.
Keep copies of recall notices, model numbers, purchase receipts, and all communications with the manufacturer and clinicians.
Model numbers: MMT-1711, MMT-1712, MMT-1751, MMT-1752. Sold worldwide; US nationwide distribution. No specific sale dates or price information provided.
No injuries or incidents have been reported.
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