Date Issued: June 27, 2019
The FDA is warning patients and health care providers that certain Medtronic MiniMed™ insulin pumps have potential cybersecurity risks. Patients with diabetes using these models should switch their insulin pump to models that are better equipped to protect against these potential risks.
Medtronic is recalling the following affected MiniMed pumps and providing alternative insulin pumps to patients.
|Pump Model||Software Version|
|MiniMed™ 508||All versions|
|MiniMed™ Paradigm™ 511||All versions|
|MiniMed™ Paradigm™ 512/712||All versions|
|MiniMed™ Paradigm™ 515/715||All versions|
|MiniMed™ Paradigm™ 522/722||All versions|
|MiniMed™ Paradigm™ 522K/722K||All versions|
|MiniMed™ Paradigm™ 523/723||Version 2.4A or lower|
|MiniMed™ Paradigm™ 523K/723K||Version 2.4A or lower|
|MiniMed™ Paradigm™ 712E*||All versions|
|MiniMed™ Paradigm™ Veo 554CM/754CM*||Version 2.7A or lower|
|MiniMed™ Paradigm™ Veo 554/754*||Version 2.6A or lower|
* Available outside the United States only.
- Check to see if the model and software version of your insulin pump is affected. Read the Medtronic Patient Letter to learn how to identify your pump’s software version. If you live outside the United States, Medtronic will send you a notification letter with instructions based on the country where you live.
- Talk to your health care provider about a prescription to switch to a model with more cybersecurity protection.
- If you have questions about replacing your pump, call Medtronic at 1-866-222-2584 or go to Medtronic’s website.
To minimize the potential risk of a cybersecurity attack while you are waiting for a replacement pump:
- Keep your insulin pump and the devices that are connected to your pump within your control at all times whenever possible.
- Do not share your pump serial number.
- Be attentive to pump notifications, alarms, and alerts.
- Monitor your blood glucose levels closely and act appropriately.
- Immediately cancel any unintended boluses.
- Connect your Medtronic insulin pump to other Medtronic devices and software only.
- Disconnect the USB device from your computer when you are not using it to download data from your pump.
Get medical help right away if you:
- Have symptoms of severe hypoglycemia (such as excessive sweating, feeling very tired, dizzy and weak, being pale, and a sudden feeling of hunger).
- Have symptoms of diabetic ketoacidosis (such as excessive thirst, frequent urination, nausea and vomiting, feeling very tired and weak, shortness of breath).
- Think your insulin pump settings or insulin delivery changed unexpectedly.