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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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.
Unintended insulin delivery due to pump height relative to the infusion site. Over-delivery can cause severe hypoglycemia and potentially death. Under-delivery can cause severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Medtronic MiniMed or your healthcare provider for instructions. 3. Follow the recall letter instructions. 4. Do not discard the device until instructed. 5. If you seek a refund or replacement, follow Medtronic's recall instructions.
Phone: Unknown. Website: https://www.medtronic.com. Hours: Unknown.
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