Medical device company Medtronic (NYSE: MDT) is recalling several types of insulin pumps because of a dangerous flaw. According to an announcement from the U.S. Food and Drug Administration (FDA), the devices in question are being recalled because they may be incorrectly dosing insulin. The recall includes about 322,000 devices.
Insulin pumps are devices that are designed to deliver exact doses of insulin based on a person’s blood sugar levels. They are used to help diabetes patients reach desired blood glucose levels as part of their management of the disease. The FDA announcement identified the recall as a Class I recall, the most serious type of recall that is used for products that could result in serious injury or death.
The pumps affected by the recall include Medtronic MiniMed Models 630G/MMT-1715 and 670G/MMT-1770. The 630G recall includes lots distributed from September to October 2019 and intended for use by people 16 and older. The 670G recall involves lots distributed from June 2017 to August 2019 and intended for use by people 14 and older. Any users of these devices are encouraged to talk to their doctors to switch to another way to administer insulin.
Medtronic first alerted patients about potential problems with the pumps in November. It was found that faulty retainer rings were causing some of the devices to deliver too much or too little insulin. Medtronic has thus far received 26,421 complaints about the rings, resulting in at least 2,175 injuries and one death.
Delivering too much or too little insulin could result in life-threatening complications, especially in people with Type 1 diabetes. An incorrect dosage could lead to hypoglycemia, known as having low blood sugar, or hyperglycemia, known was having high blood sugar. Hypoglycemia symptoms include dizziness, confusion, and feelings of weakness. Severe cases of hyperglycemia can result in loss of consciousness, seizure, or death.