FDA Device recall Z-0193-2023
Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754
- FDA Device
- Class II
- ongoing
- Published 2022-11-16
On 2022-11-16 the FDA classified a Class II recall of Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754 by Medtronic Minimed, citing medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0193-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-20 |
| Published | 2022-11-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Minimed |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, VT, WA, WI, WV, WY |
Product
Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
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.
Identifiers
| code_info | Model/UDI-GTIN(All Serial Numbers): MMT-1715/643000000000, 763000072520, 643169873834, 00643169656840; MMT-1755/6431697…Model/UDI-GTIN(All Serial Numbers): MMT-1715/643000000000, 763000072520, 643169873834, 00643169656840; MMT-1755/643169752726, 643169873841, 643169878648, 763000179632, 00643169752726; MMT-1754/643169976344; MMT-1780/643169949706, 643169939202, 763000072537, 643000000000, 00643169939219; MMT-1781/763000187415, 763000283568, 00763000140601, 00763000225575, 00763000235765, 00763000187415, 00763000283551, 00763000240707; MMT-1782/763000187422, 763000283599, 00763000140618, 00763000225612, 00763000235772, 00763000187422, 00643169957640, 00763000283582; MMT-1760/643169946040, 763000278427, 763000179649, 643169946057, 763000367084, 00643169946057; MMT-1761/00763000367657, 00763000165413; MMT-1762/00763000239404, 00763000203313, 00763000216481, 00763000187408, 00763000165475; MMT-1740/Investigational; MMT-1741/00763000303556, 00763000408916; MMT-1742/00763000250232 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Medtronic Minimed
- Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062
FDA Device · Class II · 2026-10-14 · Medtronic Minimed - MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
FDA Device · Class II · 2026-07-29 · Medtronic Minimed
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0193-2023%22
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