Medtronic MiniMed Legal Helpline℠
The US Food and Drug Administration (FDA) has issued a Class I Recall of Medtronic MiniMed™ 600 Series insulin pumps used for the management of diabetes. Class I recalls are the most serious type of recall issued by the FDA, indicating that the defective products may cause serious injuries or death.
The devices impacted by the recall are:
- Model 630G—Distributed from September 2016 to February 2020
- Model 670G—Distributed May 2015 to December 2020
463,464 devices have been recalled in the U.S. to date
Defect Can Cause Serious Injury or Death
Due to a missing or broken retainer ring, the device can deliver incorrect insulin doses, resulting in serious medical issues, including:
- Diabetic ketoacidosis
People with Type I diabetes may use the MiniMed insulin pump for insulin delivery to manage their diabetes.
630G Insulin Pump: May be used by people 16 years of age and older
670G Insulin Pump: May be used by people 7 years of age and older
Medtronic informed customers about possible missing or broken clear retainer rings in the 630G and 670G pumps. The purpose of the retainer ring is to lock the insulin cartridge in place in the pump’s reservoir compartment. If the cartridge is not locked in place, too little or too much insulin can be delivered to the user.
Hypoglycemia is a condition when blood sugar or glucose level is lower than normal. This condition can cause unconsciousness, seizures, and if left untreated, coma and even death. If a retainer ring is broken or becomes detached from the insulin pump, a rapid and potentially dangerous infusion of insulin can be delivered to the body, resulting in hypoglycemia.
Hyperglycemia is an excess of sugar or glucose in the bloodstream, which can cause health complications, including diabetic ketoacidosis, a dangerous condition that occurs when excess ketones develop in the blood, which can cause coma or death. If the retainer ring doesn’t lock the reservoir in place, the pump is prevented from pushing insulin into the body. The pump can also stop working if water enters the insulin pump.
If you or a loved one suffered an injury or death after using the MedTronic MiniMed insulin pump, you may be entitled to compensation.
Call Legal Helpline for a free case review, or visit minimedclaims.com for more information