USA – FDA has issued a class 1 recall this is the most serious recall. Issued when a product can cause death or has, and requires immediate discontinued use.
Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump’s reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death.
The firm has received a total of 26,421 complaints in which the device malfunctioned in this manner. The firm is aware of 2,175 injuries and 1 death.
Models 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
Date Initiated by Firm: November 21, 2019
What to Do
On November 21, 2019 Medtronic notified affected customers and advised them to:
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.
More info here: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-minimed-insulin-pumps-incorrect-insulin-dosing?c
