Medtronic MiniMed recalled 37,458 insulin pumps sold worldwide through healthcare providers, including the MiniMed 720G, after finding that a pump raised above or lowered relative to the infusion site can deliver insulin too much or too little. The defect stems from changes in gravitational force affecting hydrostatic and hydrodynamic pressures at the infusion site. Patients should stop using the
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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Product: MiniMed 720G Insulin Pump. Model numbers include MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867. Sold worldwide through healthcare providers and medical supply channels. Sold since: Unknown. Price: Unknown. Distribution: Worldwide.
The device can unintentionally deliver more insulin when the pump sits above the infusion site or less insulin when it is below it. This is driven by gravitational forces altering hydrostatic and hydrodynamic pressures. Over-delivery risks severe hypoglycemia and death. Under-delivery risks severe hyperglycemia, dehydration, diabetic ketoacidosis, and death.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by the manufacturer. 3. Contact Medtronic MiniMed or your healthcare provider for instructions. 4. For refund or replacement details, refer to the recall notice and contact information provided by the manufacturer at the FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1745-2026
Phone: Unknown. Website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1745-2026. Hours: Unknown.
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