The Food and Drug Administration (FDA) on Feb. 12 alerted health care providers to a Class I recall of two Medtronic MiniMed insulin pump models due to improper dosing.
The recall affects lots of Model 630G (MMT-1715) distributed between September 2016 and October 2019 and lots of Model 670G (MMT-1780) distributed from June 2017 to August 2019. These models have a missing or broken retainer ring that locks the insulin cartridge into the pump’s reservoir compartment. If not locked into place, the cartridge could deliver too much or too little insulin, resulting in hypoglycemia or hyperglycemia. More than 300,000 devices are affected, and Medtronic has been alerted of 2,175 related injuries and one death.
Medtronic users should examine their pump’s retainer ring and stop use if the reservoir does not lock into the pump or the retainer ring is loose, damaged, or missing. Those who stop using the pump should follow their physicians’ recommendations and perform manual injections. If the reservoir locks in place correctly, users should check the pump retainer ring after every set change.
FDA advises providers to report adverse reactions or quality problems associated with the affected products to the agency’s MedWatch Safety Information and Adverse Event Reporting Program. For more information about replacing a pump, contact Medtronic at 877.585.0166.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions