Medtronic MiniMed recalled 73,656 Paradigm insulin pumps sold worldwide, including broad U.S. distribution, after a risk of unintended insulin delivery. The issue affects Paradigm, 600-series and BLE 700-series pumps. It can cause life-threatening highs or lows in insulin delivery. Stop using the device and follow recall instructions immediately.
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 include 643169999770, 643169729360, 763000065201, 763000069001, 763000192228, 763000198602, 763000155346, 763000192143, 763000258344, 763000317140, 763000404567, 763000317188, 763000317195, 763000367046, 763000317157, 00613994470492, 00643169496262, 643169577664, 643169577688, 643169577695. Sold worldwide with US distribution noted. No price data provided.
All Medtronic MiniMed infusion pumps in the Paradigm series, 600 series and BLE 700 series can deliver insulin in error when the pump height relative to the infusion site changes. Elevation can cause insulin over-delivery. Lowering the pump can cause insulin under-delivery. Over-delivery risks include severe hypoglycemia, altered mental status, seizures, coma and death. Under-delivery risks include severe hyperglycemia, dehydration, diabetic ketoacidosis and 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 instructions provided by the manufacturer. 4. If instructed, arrange for refund or replacement as directed by Medtronic. 5. Keep records of communications and devices involved.
Phone: Unknown. Website: https://www.medtronic.com. Hours: Unknown.
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