FDA Alert – Medtronic Recalls Paradigm and 508 MiniMed Insulin

The FDA has identified this as a Class I recall, the most serious type of recall. The use of these devices may cause serious injuries or death.

Recalled Product

All MiniMed Remote Controllers (model MMT-500 and MMT-503) are used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps.

Reason for Recall

Medtronic is recalling all remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump. Using specialized equipment, an unauthorized person could instruct the pump 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, even death.

If you have never programmed a remote controller ID into the pump and never programmed the easy bolus option, you are not impacted by this vulnerability.

Click here for more details about the recall.