MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
Class I - DangerousWhat Should You Do?
- Check if you have this product: NG1019903H NG1019906H NG1019907H NG1019909H NG1019914H NG1019915H NG1019916H NG1019918H NG1019921H NG1019922H NG1019923H NG1019925H NG1019926H NG1019928H NG1019930H NG1019931H NG1019932H NG1019933H NG1019935H NG1019937H NG1019939H NG1019940H NG1019943H NG1019944H NG1019946H NG1019949H NG1019950H NG1019953H NG1019966H NG1019971H NG1019975H NG1019976H NG1019979H NG1019981H NG1019989H NG1019997H NG1019999H NG1020001H NG1020006H NG1020007H NG1020012H NG1020015H NG1020017H NG1020018H NG1020019H NG1020020H NG1020022H NG1020023H NG1020026H NG1020027H NG1020028H NG1020029H NG1020031H
- 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:
- The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
Product Codes/Lot Numbers:
NG1019903H NG1019906H NG1019907H NG1019909H NG1019914H NG1019915H NG1019916H NG1019918H NG1019921H NG1019922H NG1019923H NG1019925H NG1019926H NG1019928H NG1019930H NG1019931H NG1019932H NG1019933H NG1019935H NG1019937H NG1019939H NG1019940H NG1019943H NG1019944H NG1019946H NG1019949H NG1019950H NG1019953H NG1019966H NG1019971H NG1019975H NG1019976H NG1019979H NG1019981H NG1019989H NG1019997H NG1019999H NG1020001H NG1020006H NG1020007H NG1020012H NG1020015H NG1020017H NG1020018H NG1020019H NG1020020H NG1020022H NG1020023H NG1020026H NG1020027H NG1020028H NG1020029H NG1020031H
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0437-2016
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)
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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)
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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.