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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic MiniMed
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
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
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0193-2023
Related Recalls
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
Medtronic MiniMed
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
Medtronic MiniMed
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.