Medtronic’s insulin pump product, MiniMed 508 Paradigm, has been recalled after the pumps exhibited potential cyber security risks, according to a statement issued from the Food and Drug Administration on Thursday.
Medtronic is a medical technology company headquartered in Dublin, Ireland; its diabetes division is in Northridge.
“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 with cybersecurity vulnerabilities,” the organization said in a statement.
“This person could 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.”
There are no confirmed reports of unauthorized persons changing settings or controlling delivery, according to Medtronic.
The company issued a letter to customers and their doctors with recommended security precautions when using their insulin pump. The FDA suggests patients with a Medtronic pump check the model and software version to see if they are affected.
Shares of Medtronic plc (MDT) closed Thursday up 26 cents, or less than one percent, to $97.48 on the New York Stock Exchange.