MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 530G: 00643169507784, 00643169736061, 00643169736092, 00643169736085, 00643169933224, 00763000161170: Artwork, CRB A Process, Instr, 530G, One Press, Launch, US(MP6026081-012DOC); Artwork, CRB A Process, Instr, 530G, FDA comments, add TST(MP6025813-013DOC); Artwork, CRB A Process, Instr, 530G, Remove Velcro, Icons, US(MP6025813-014DOC);
- 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:
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Product Codes/Lot Numbers:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 530G: 00643169507784, 00643169736061, 00643169736092, 00643169736085, 00643169933224, 00763000161170: Artwork, CRB A Process, Instr, 530G, One Press, Launch, US(MP6026081-012DOC); Artwork, CRB A Process, Instr, 530G, FDA comments, add TST(MP6025813-013DOC); Artwork, CRB A Process, Instr, 530G, Remove Velcro, Icons, US(MP6025813-014DOC);
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1751-2026
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.