FDA Notification Recall on Insulin Pumps

The FDA has identified this as a Class I recall, the most serious type of recall. The use of these devices may cause serious injuries or death.

Recalled Product

  • MiniMed™ 600 Series Insulin Pumps
  • Lot codes: Refer to the Medical Device Recalls database entry for each product.
  • Distribution Dates:
    • Model 630G - September 2016 to February 2020
    • Model 670G - May 2015 to December 2020
  • Devices Recalled in the U.S.: 463,464
  • Date Initiated by Firm: November 21, 2019

Device Use

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 seven years of age and older.

Reason for Recall

Medtronic is recalling the specified insulin pumps to replace any pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.

Click here to read the entire notification.

October 5, 2021 UPDATE: Medtronic updated this recall with information that Medtronic will replace any MiniMed™ 600 series insulin pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump. If you have questions about this recall, call Medtronic’s 24-Hour Technical Support line: 1-877-585-0166.