Medtronic MiniMed Insulin Pump Recall News – Medtronic has issued a recall for its MiniMed Insulin Pump product due to incorrect insulin dosing.
The U.S. Food and Drug Administration’s (FDA) has classified this as a Class I Recall. A Class I Recall is the most serious type of recall and use of these MiniMed Insulin Pumps may cause serious injury or death.
Medtronic MiniMed Insulin Pump Recall Information
On November 19, 2019, with updates to the FDA as of February 12, 2020, Medtronic initiated a recall for its MiniMed Insulin Pump products due to incorrect insulin dosages. Individuals with Type 1 diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes.
The following information is subject to this specific MiniMed Insulin Pump recall:
- MiniMed 600 Series Insulin Pumps
- Model 630G (MMT-1715) – all lots before October 2019
- May be used by persons sixteen years of age and older
- Model 670G (MMT-1780) – all lots before August 2019
- May be used by persons seven years of age and older
- Model 630G (MMT-1715) – all lots before October 2019
- Distribution Dates:
- Model 630G – September 2016 to October 2019
- Model 670G – June 2017 to August 2019
- Devices Recalled in the U.S.: 322,005
Per the FDA’s announcement,
Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump’s reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death.
Medtronic has received a total of 26,421 complaints in which their MiniMed Insulin Pump device malfunctioned in the above manner. Medtronic is aware of 2,175 injuries and 1 death related to the affected device.
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