Medtronic is recalling certain MiniMed 600 Series insulin pumps due to a missing or broken retainer ring that can potentially lead to the under or over delivery of insulin. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.
The recalled products include:
- MiniMed 630G (MMT-1715) for all lots before October 2019 that were distributed between September 2016 to October 2019.
- MiniMed 670G (MMT-1780) for all lots before August 2019 that were distributed between June 2017 to August 2019.
The MiniMed insulin pumps contain a 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, patients may not receive the proper amount of insulin, which can result in either hypoglycemia or hyperglycemia.
At this time, the Company has received a total of 26,421 complaints regarding the recall, of which there have been 2175 injuries and 1 death. The Company has mailed “Urgent Field Safety Notification” letters to affected consumers and healthcare providers advising them to do the following:
- Examine the retainer ring on the 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.
This is not the first time the Company has dealt with issues regarding its insulin pumps. In June 2019, the FDA issued warnings to alert the public of potential cybersecurity risks associated with certain MiniMed series insulin pumps.
Any adverse events associated with the recall should be reported to the FDA’s MedWatch program. Consumers with questions regarding the recall can contact 24-hour Medtronic Technical Support at (877) 585-0166.
For more information visit fda.gov.