Medtronic has recalled a line of MiniMed Insulin Pumps, with the FDA calling it a Level 1 recall, its most serious level of recall.
The FDA said that the use of these devices "may cause serious injuries or death."
Pumps are being recalled due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment. Failing to keep the lock the insulin cartridge could cause hypoglycemia or hyperglycemia.
The FDA said there have been 26,421 complaints in which the device malfunctioned in this manner, causing 2,175 injuries and one death.
The affected products are:
- MiniMed 600 Series Insulin Pumps
- Model 630G (MMT-1715) - all lots before October 2019
- Model 670G (MMT-1780) - all lots before August 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
Here is what is recommended if you have a product covered by this recall:
- 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.