Recall Z-0194-2023 ยท OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Medtronic MiniMed
Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
| Date | Nov 8, 2022 (initiated Sep 20, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component change control |
| Action | On 09/20/2022, correction notices were distributed to customers, healthcare professionals, distributors, and service providers. They were informed to take the following actions: 1. Turn off the "Remote Bolus" feature on your pump if it is turned on. Note that the "Remote Bolus" capability is on by default, so take this action even if this feature has never been used. See Appendix: "How to Turn Off Remote Bolus Settings" or by visiting our website at www.medtronicdiabetes.com/remote-bolus 2. Conduct any connection linking of devices in a non-public place. 3. Complete and return the customer co |
| Quantity | 316326 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.