Medtronic MiniMed, Inc.: MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan, New Zealand, Australia, Bangladesh, Brunei Darussalam, Cambodia, Indonesia, Malaysia, Maldives, Ph Quantity: 37,458 Lot/code info: Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 720G Insulin Pump: 763000854768, 763000505196, 763000505219, 763000505318, 763000505257, 763000505295, 763000505233, 763000505370, 763000505325, 763000505332, 763000505394, 763000505356, 763000505387, 763000505349, 763000505400, 763000505226, 763000505271, 763000638016, 763000531171, 763000854751: MINIMED 720G SYSTEM USER GUIDE(M000187C022 1, M000186C002 1, M000186C014 1, M000187C016 1, M000186C021 1, M000186C018 1, M000186C017 1, M000187C010 1, M000187C011 1, M000186C031 1, M000187C013 1, M000187C008 1, M000187C015 1, M000187C005 1, M000187C033 1, M000186C028 1, M000187C023 1, M000187C020 1, M000187C018 1, M000186C018 13, M000186C004 1, M000186C030 1, M000186C009 1, M000187C024 1, M000186C033 1, M000186C003 1, M000187C012 1).

UPC codes

763000854768, 763000505196, 763000505219, 763000505318, 763000505257, 763000505295, 763000505233, 763000505370, 763000505325, 763000505332, 763000505394, 763000505356, 763000505387, 763000505349, 763000505400, 763000505226, 763000505271, 763000638016, 763000531171, 763000854751

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.