Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients and health care providers that certain Medtronic MiniMed insulin pumps have potential cybersecurity risks. The FDA has become aware that an unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pump’s settings to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis. This safety communication provides recommendations for patients who have diabetes, their caregivers, and their health care providers. The FDA is recommending that patients with diabetes using these models switch their insulin pump to models that are better equipped to protect against these potential risks. The FDA will continue working to assure Medtronic addresses this cybersecurity issue, and will keep the public informed if significant new information becomes available.

Read the Safety Communication