Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.
Reason for recall: Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access. Distribution: US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. OUS: Andorra, Australia, Austria, Barbados, Belgium, Bermuda, Bolivia, Botswana, Canada, Canary Islands, Cayman Islands, Chile, Czech Republic, Denmark, Dominican Rep., El Salvador Quantity: 316326 Lot/code info: Model/UDI-GTIN (All Serial Numbers): MMT-1750/00763000375461, 00643169559745; MMT-1711/643169554931, 763000367039, 00643169890039, 00643169554917, 00643169629813, 00643169554924, 00643169554931, 00643169742062, 00763000013066, 00643169554948, 00643169554955, 00643169621954; MMT-1712/643169662612, 643169577701, 00763000205409, 00643169890046, 00643169577664, 00643169629820, 00643169577671, 00643169577688, 00763000155346, 00643169577695, 00643169577701, 00643169621961; MMT-1751/643169672239, 00643169574410, 00643169574427, 00643169574434, 00763000253288, 00643169574441, 00643169574458, 00643169643512, 00643169521155, 00643169521704, 00763000015596, 00643169520882, 00643169521421, 00643169521971; MMT-1752/763000192181, 00643169596368, 00643169596382, 00643169596405, 00763000318291, 00763000318307, 00643169596443, 00643169522305, 00643169521292, 00643169522381, 00643169521841, 00643169522268, 00643169521025, 00643169522343, 00643169521575, 00643169522114
00763000375461, 00643169559745, 643169554931, 763000367039, 00643169890039, 00643169554917, 00643169629813, 00643169554924, 00643169554931, 00643169742062, 00763000013066, 00643169554948, 00643169554955, 00643169621954, 643169662612, 643169577701, 00763000205409, 00643169890046, 00643169577664, 00643169629820, 00643169577671, 00643169577688, 00763000155346, 00643169577695, 00643169577701, 00643169621961, 643169672239, 00643169574410, 00643169574427, 00643169574434, 00763000253288, 00643169574441, 00643169574458, 00643169643512, 00643169521155, 00643169521704, 00763000015596, 00643169520882, 00643169521421, 00643169521971
Official record: FDA (Device enforcement) ↗
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