Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711 — Class II medical device recall Z-0194-2023
Ongoing recall by Medtronic MiniMed, reported 2022-11-16, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated w
| Recall number | Z-0194-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Northridge, CA, United States |
| Recall initiated | 2022-09-20 |
| Classified | 2022-11-07 |
| Reported by FDA | 2022-11-16 |
| Distributed | 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 |
| Countries outside the US | AT, AU, BB, BE, BM, BO, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HU, IE, IL, IT, KE, KY, LU, MX, NL, NO, NZ, PE, PL, PT, PY, RO, SE, SK, SV, TR, TT, VE, ZA |
| Quantity | 316,326 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00643169520882, 00643169521025, 00643169521155, 00643169521292, 00643169521421, 00643169521575, 00643169521704, 00643169521841, 00643169521971, 00643169522114, 00643169522268, 00643169522305, 00643169522343, 00643169522381, 00643169554917, 00643169554924, 00643169554931, 00643169554948, 00643169554955, 00643169559745, 00643169574410, 00643169574427, 00643169574434, 00643169574441, 00643169574458 and 29 more |
| Serial numbers | 00643169520882, 00643169521025, 00643169521155, 00643169521292, 00643169521421, 00643169521575, 00643169521704, 00643169521841, 00643169521971, 00643169522114, 00643169522268, 00643169522305, 00643169522343, 00643169522381, 00643169554917, 00643169554924, 00643169554931, 00643169554948, 00643169554955, 00643169559745, 00643169574410, 00643169574427, 00643169574434, 00643169574441, 00643169574458 and 31 more |
Product
Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0194-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.