Medtronic MiniMed recalled 799 infusion pumps worldwide, including in the United States. The devices in the Paradigm, 600, and BLE 700 series can deliver too much or too little insulin when their height relative to the infusion site changes due to gravity. Stop using the pump immediately and contact Medtronic MiniMed for instructions on replacement or refund.
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 automate or assist insulin delivery for diabetes management. The 620G is part of older Paradigm/600 BLE lines and may connect with continuous glucose monitoring systems.
The device's height relative to the infusion site affects hydrostatic and hydrodynamic pressures, causing potential insulin over-delivery or under-delivery.
This recall is not presented as part of a broader industry pattern in the provided data.
Patients may experience severe hypo- or hyperglycemia, requiring urgent medical care. The recall affects 799 units across a wide distribution network worldwide.
Device labels, user manuals, recall notices, FDA enforcement page
Refunds or replacements typically take 4-8 weeks after submission
Keep all recall notices, device serial numbers, photos of labels, receipts, and all correspondence with Medtronic.
Model numbers and devices affected include MiniMed 620G insulin pump and related Paradigm, 600, and BLE 700 series pumps. Distribution is worldwide, including US states and many countries.
No injuries or incidents have been reported.
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