Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-17...
FDA Device Recall #Z-0193-2023 — Class II — September 20, 2022
Recall Summary
| Recall Number | Z-0193-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 20, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic MiniMed |
| Location | Northridge, CA |
| Product Type | Devices |
| Quantity | 399651 |
Product Description
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 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 Pattern
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, Faroe Islands, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Kenya, Liechtenstein, Luxembourg, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, Uganda, United Kingdom, Venezuela
Lot / Code Information
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
Other Recalls from Medtronic MiniMed
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0776-2023 | Class II | Guardian iOS app (MMT-8200) and Guardian Androi... | Nov 21, 2022 |
| Z-0194-2023 | Class II | Insulin Pump/Model: MiniMed 620G/ MMT-1750 Mi... | Sep 20, 2022 |
| Z-1354-2022 | Class II | MiniMed 640G Insulin Pump (O.U.S. Version) | May 23, 2022 |
| Z-1356-2022 | Class II | MiniMed 720G Insulin Pump (O.U.S. Version) | May 23, 2022 |
| Z-1357-2022 | Class II | MiniMed 740G Insulin Pump (O.U.S. Version) | May 23, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.