The FDA has announced a Class 1 recall of 322,000 MiniMed 600 Series insulin pumps. The agency has categorized this recall as the most serious type as the product may cause serious injury or death.
Medtronic, the company that manufactures the insulin pumps, has revealed that more than 2,000 users have been injured and at least one person has died from the malfunction.
MiniMed 600 Series Insulin Pumps
- Model 630G (MMT-1715) – all lots before October 2019
- Model 670G (MMT-1780) – all lots before August 2019
- 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
Medtronic revealed that the insulin pumps in question had a missing or broken retainer ring. This ring is supposed to lock the insulin cartridge in place so that it can function properly. In the malfunctioning units, users were receiving the wrong dosage of insulin, sometimes resulting in dangerously elevated blood sugar.
For people with Type 1 diabetes, it is very important to maintain healthy, controlled levels of blood sugar by using insulin. Severe hyperglycemia (elevated blood sugar) can lead to the person experiencing seizures or even death. That appears to be the case with the death involved in this recall.
What You Should Do
Although Medtronic contacted customers and healthcare providers in November about this issue, the FDA has just now released the details of the recall. If you didn’t receive a notice, however, don’t assume that you are unaffected.
The FDA and Medtronic recommend that users of this insulin pump should check to see if the retainer ring appears to be in one piece. If it seems to be damaged in any way, they should contact their doctor and stop using the pump.
Medtronic will provide a replacement pump for affected customers. You can contact the company’s 24-hour hotline at 877-585-0166.