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Drug Safety Alerts
MiniMed 600 Series Insulin Pumps by Medtronic Class I Recall
2/12/2020
On February 12, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a Class I recall of MiniMed 600 Series Insulin Pumps manufactured by Medtronic. This recall was issued 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.
This recall affects
- Model 630G (MMT-1715) - all lots before October 2019
- Model 670G (MMT-1780) - all lots before August 2019
People who have Type 1 diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes.
The Model 630G insulin pump may be used by persons sixteen years of age and older.
The Model 670G insulin pump may be used by persons fourteen years of age and older.
Medtronic has received a total of 26,421 complaints in which the device malfunctioned in this manner. Medtronic is aware of 2,175 injuries and 1 death.
Medtronic notified affected patients and advised them to:
- Examine the retainer ring of their pump.
- Stop use of the pump and contact Medtronic for a replacement pump if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing. If you stop using the pump, you should follow your doctor's recommendations and perform manual insulin injections.
- Continue using the pump if the reservoir locks in place correctly.
- If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.
- Check the pump retainer ring and verify that the reservoir is locked correctly at every set change.
CVS Caremark Response: Because of this action, CVS Caremark® is sending letters to members who received this product through CVS Caremark® Mail Service Pharmacy and their physicians
For more information, please contact Medtronic Technical Support at 1-877-585-0166 or visit www.medtronicdiabetes.com/PumpRing. You may also contact the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.