Medtronic MiniMed recalled 24,946 MiniMed 740G insulin pumps worldwide after identifying unintended insulin delivery when the pump height changes relative to the infusion site. The defect can cause over-delivery or under-delivery of insulin due to gravity-driven pressure changes. Patients should stop using the device and contact Medtronic MiniMed for instructions on recall steps, refunds or a swap
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-1811, MMT-1812, MMT-1861, MMT-1862. Product: MiniMed 740G Insulin Pump. Distribution: Worldwide. Sold since: Unknown. Price: Unknown.
Unintended insulin delivery occurs when the pump is elevated relative to the infusion site, potentially causing severe hypoglycemia. Lowering the pump relative to the site can lead to under-delivery and severe hyperglycemia or diabetic ketoacidosis. Changes in gravitational force affect hydrostatic and hydrodynamic pressures inside the infusion system.
No injuries or incidents have been reported.
1. Stop using the product. 2. Review the recall instructions from Medtronic MiniMed. 3. Contact Medtronic MiniMed or your healthcare provider for instructions on recall, refunds or replacements. 4. If you experience symptoms of hypoglycemia or hyperglycemia, seek medical care promptly. 5. Refund or replacement information: contact Medtronic MiniMed for instructions.
Phone: Unknown. Website: Unknown. Hours: Unknown.
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