Medtronic has recalled some of its insulin pumps after one death and more than 2,000 injuries were reported, according to a Wednesday announcement from the Food and Drug Administration. Certain Medtronic MiniMed 600 Series pumps were administering incorrect insulin doses to diabetes patients.
The FDA said the recall is a Class I, the most serious type of recall.
The company is recalling these particular pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment, the FDA announcement said. If that cartridge is not locked firmly in place, "under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia" -- a condition which, if severe enough, can lead to loss of consciousness, seizure and death.
The company has received 26,421 complaints in which the device malfunctioned in the manner described above. The firm is aware of 2,175 injuries and 1 death, the FDA announcement said.
Recalled Product Details
- 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
- Date Initiated by Firm: Nov. 21, 2019
What to Do
A letter sent to "affected customers" from Medtronic in November advised them to examine the retainer ring of their pumps and to stop use of the pump "if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing."
If the retainer ring does not appear to function properly, users can contact Medtronic for a replacement pump. Anyone who stops using the pump should follow their doctor's recommendations and perform manual insulin injections.
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.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
App users, click below to read in full the company's letter to affected users.