Paradigm Insulin Pump (MMT-712, MMT-715)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Insulin Pump: 643169999770, 643169729360, 763000065201, 763000069001, 763000192228, 763000198602, 763000155346, 763000192143, 763000258344, 763000317140, 763000404567, 763000317188, 763000317195, 763000367046, 763000317157, 00613994470492, 00643169496262, 643169577664, 643169577688, 643169577695, 643169739512, 00613994332929, 00613994469694, 00613994470904, 00763000084271, 00763000161019, 643169577701, 643169739512, 643169662612, 00643169533776, 00763000084370, 643169656840, 763000090197, 763000190439, 763000316631, 00613994473820, 00643169478503, 00613994151766, 00643169710368, 00763000161057, 00613994326478, 00613994326508, 00613994395771, 00613994395719, 00613994395696, 00613994527851, 00643169729421, 00643169198920, 00643169572447, 00643169198890, 00613994527868, 00613994172129, 00613994172419, 00613994171627, 00613994171344, 00613994172211, 00613994172525, 00613994172334, 00613994172044, 00613994172761, 00613994171917, 00613994326621, 00613994326584, 00643169848825, 00643169848832, 00643169848801, 00613994395818, 00613994395764, 00613994395740, 00613994394132, 00763000069209, 00763000069179, 00613994527905, 00763000069162, 00613994527769, 00613994405876, 00763000069186, 00763000069148, 00613994527783, 00613994527806, 00613994527899, 00613994527790, 00613994527882, 00613994527837, 00643169198968, 00643169198883, 00643169198944, 00643169198906, 00763000084301, 00613994527745, 00643169198975, 00643169035515, 00643169201927, 00643169198913, 00643169198937, 00613994475268, 00643169198999, 00643169198982, 00643169503120, 00763000187507, 00643169198951, 00643169848818, 00643169848795, 00643169848771, 00613994527738, 00613994171443, 00613994171528, 00613994326539, 00613994326560, 00613994395726, 00613994395757, 00763000102616, 00763000069155, 00613994473868, 00763000004262, 00763000084318, 00763000161064, 76300031665503, 763000316655, 643169656840, 763000367053, 763000090197, 763000166519, 763000072520, 763000190439, 76300031665501, 763000316631, 763000256807: INSTR,US,FINE TUNING,PUMP,512/712 (6024948-012 3); INSTR,US,FINE TUNING,PUMP,PRDGM (6024948-013 1); INSTR,EN,FINE TUNING,PUMP (6024948-021 3); INSTR,US,PUMPS,PRDGM,515/715 (6025020-017 1); INSTR., 515/715, PRDGM, US (6025020-018 2); INSTR, 515/715, MDD, EN (6025020-024 1); INSTR, 515/715, EURO-E, MDD (6025020-025 2); INSTR., X15, EN OUS (6025020-026 1)
- 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, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Paradigm Insulin Pump (MMT-712, MMT-715)
Product Codes/Lot Numbers:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Insulin Pump: 643169999770, 643169729360, 763000065201, 763000069001, 763000192228, 763000198602, 763000155346, 763000192143, 763000258344, 763000317140, 763000404567, 763000317188, 763000317195, 763000367046, 763000317157, 00613994470492, 00643169496262, 643169577664, 643169577688, 643169577695, 643169739512, 00613994332929, 00613994469694, 00613994470904, 00763000084271, 00763000161019, 643169577701, 643169739512, 643169662612, 00643169533776, 00763000084370, 643169656840, 763000090197, 763000190439, 763000316631, 00613994473820, 00643169478503, 00613994151766, 00643169710368, 00763000161057, 00613994326478, 00613994326508, 00613994395771, 00613994395719, 00613994395696, 00613994527851, 00643169729421, 00643169198920, 00643169572447, 00643169198890, 00613994527868, 00613994172129, 00613994172419, 00613994171627, 00613994171344, 00613994172211, 00613994172525, 00613994172334, 00613994172044, 00613994172761, 00613994171917, 00613994326621, 00613994326584, 00643169848825, 00643169848832, 00643169848801, 00613994395818, 00613994395764, 00613994395740, 00613994394132, 00763000069209, 00763000069179, 00613994527905, 00763000069162, 00613994527769, 00613994405876, 00763000069186, 00763000069148, 00613994527783, 00613994527806, 00613994527899, 00613994527790, 00613994527882, 00613994527837, 00643169198968, 00643169198883, 00643169198944, 00643169198906, 00763000084301, 00613994527745, 00643169198975, 00643169035515, 00643169201927, 00643169198913, 00643169198937, 00613994475268, 00643169198999, 00643169198982, 00643169503120, 00763000187507, 00643169198951, 00643169848818, 00643169848795, 00643169848771, 00613994527738, 00613994171443, 00613994171528, 00613994326539, 00613994326560, 00613994395726, 00613994395757, 00763000102616, 00763000069155, 00613994473868, 00763000004262, 00763000084318, 00763000161064, 76300031665503, 763000316655, 643169656840, 763000367053, 763000090197, 763000166519, 763000072520, 763000190439, 76300031665501, 763000316631, 763000256807: INSTR,US,FINE TUNING,PUMP,512/712 (6024948-012 3); INSTR,US,FINE TUNING,PUMP,PRDGM (6024948-013 1); INSTR,EN,FINE TUNING,PUMP (6024948-021 3); INSTR,US,PUMPS,PRDGM,515/715 (6025020-017 1); INSTR., 515/715, PRDGM, US (6025020-018 2); INSTR, 515/715, MDD, EN (6025020-024 1); INSTR, 515/715, EURO-E, MDD (6025020-025 2); INSTR., X15, EN OUS (6025020-026 1)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1748-2026
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.