Medtronic recalled 453,144 MiniMed 780G insulin pumps worldwide after reports of unintended insulin delivery when the pump height changes relative to the infusion site. The defect stems from gravity-driven pressure changes affecting hydrostatic delivery. Patients and caregivers should stop using the devices immediately and follow the recall notice, contacting Medtronic MiniMed or their clinician’s
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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The MiniMed 780G insulin pump automates insulin delivery for people with diabetes. It integrates with continuous glucose monitors to modulate insulin dosing.
The recall cites gravity-related pressure changes that alter insulin delivery as the pump height relative to the infusion site changes. Over-delivery risks hypoglycemia; under-delivery risks hyperglycemia and ketoacidosis.
This recall is not described as part of a broader industry pattern.
Users may experience dangerous glucose fluctuations. Notification was by letter to device owners.
Recall letter, FDA enforcement page, and Medtronic’s recall information site
No specific timeline provided for refunds or replacements. Follow manufacturer instructions.
Save recall notices, model numbers, and any correspondence. Take photos of the device and packaging for records.
Model numbers: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896. Sold worldwide; US distribution across all states and territories. Price: Unknown. Sold date: Unknown.
No injuries or incidents have been reported.
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