FDA Issues Class I Recall of Certain Medtronic Insulin Pumps
Editor’s Note: This developing story will be updated as more information becomes available.
The U.S. Food and Drug Administration (FDA) announced today that it has issued a recall of Medtronic MiniMed 600 Series insulin pumps as a result of problems reported with incorrect insulin dosing. This recall has been classified as a Class I recall, which is the most serious type of recall that can be issued. Use of Class I recalled devices can result in grievous injury or death.
Affected pumps are being recalled because of a missing or broken retainer ring, which works to keep the insulin cartridge in place within the pump reservoir. If that cartridge is not properly secured, insulin can be under- or over-delivered, resulting in hypo- or hyperglycemia.
According to the FDA, Medtronic has received a total of 26,421 complaints over this specific issue with the device, and the defect has been tied to 2,175 injuries and one death that the company knows of.
This news follows Medtronic issuing an “Urgent Field Safety Notification” for MiniMed 630G and 670G pumps in November of 2019, stating at the time that there had been reported incidents of the pump reservoir becoming loose when the retainer ring is broken or missing.
Pamela Reese, Medtronic’s director of Global Communications, said “This recent classification of the recall does not introduce any new issues or generate new instructions for customers to return product that is working properly.”
Affected models include the MiniMed 630G (Model # MMT-1715, distributed September 2016 to October 2019) and the MiniMed 670G (Model # MMT-1780, distributed June 2017 to August 2019).
The above photo from Medtronic shows the location of the retainer ring and what it should look like. The FDA advises customers who utilize a Medtronic MiniMed 600 Series pump to do the following:
- Examine the retainer ring of the pump.
- Stop using the pump and contact Medtronic for a replacement if the reservoir does not lock in properly or the retainer ring is loose, damaged, or missing. Perform manual insulin injections and follow your healthcare provider’s instructions if you stop using your pump.
- Continue using your Medtronic pump if the reservoir correctly locks into place.
- If the pump is accidentally dropped or bumped, check to ensure that the retainer ring is not damaged.
- Check to make sure the retainer ring is not broken, damaged or missing and that the reservoir is properly secured during every set change.
Reese also said that, “Medtronic will replace pumps that have damage to the retainer ring and advises customers to examine their pump retainer ring during each infusion set and reservoir change to ensure the reservoir locks in place.”
Customers who have questions or need additional information or support about this recall should call the 24-hour Medtronic Technical Support at 877-585-0166.