Medtronic is recalling more than 322,000 of its insulin pumps because of a missing or broken component that can lead to over- or under-delivery of insulin. The problem is linked to one death, according to the U.S. Food and Drug Administration.
The recall is a “class I” recall, which the FDA says is “the most serious type of recall.”
“Use of these devices may cause serious injuries or death,” the FDA said in the recall notice.
Medtronic has received more than 26,000 complaints about the devices malfunctioning in this way, and is aware of 2,175 injuries and one death, the FDA said.
In November, Medtronic advised diabetics who use the device to examine the retainer ring of the pump, and to stop using the pump if the reservoir doesn’t lock into the pump or if the retainer ring is loose, damaged or missing.
It’s not the first time Medtronic has recalled its MiniMed devices. In June, the company recalled severalbecause of a cybersecurity risk that could allow hackers to take control of the devices remotely and change their settings.
The recalled products 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