Abbott released an update to its implantable pacemakers as part of its ongoing commitment to continuously improve patient care. This planned update to pacemaker firmware (a kind of software) adds additional security protections designed to reduce the risk of unauthorized access to patients' pacemakers.
Speak to your physician to see if this update is right for you.
What you need to know about the pacemaker firmware update
Firmware is a kind of software that is embedded in the hardware of the pacemaker device. Technological devices that use software, such as that in your pacemaker, require updates from time to time.
The update contains a software release that includes data encryption, operating system patches, and the ability to disable network connectively features, in addition to the firmware update.
The pacemaker devices to which this update applies include the RF telemetry versions of the following devices in the U.S.: Accent SR RF™, Accent MRI™, Assurity™, Assurity MRI™, Accent DR RF™, Anthem RF™, Allure RF™, Allure Quadra RF™, and Quadra Allure MP RF™.
Every pacemaker manufactured beginning Aug. 28, 2017, will have this update pre-loaded in the device and those devices will not need to be updated. Based on Abbott's consultation with U.S. Food and Drug Administration (FDA), this update is being treated as a field action; however, the devices continue to function as intended and replacement of implanted pacemaker devices is not recommended.
How likely is it that someone could gain unauthorized access to my device?
We have received no reports of unauthorized access to any patient’s implanted pacemaker. According to the advisory issued by the U.S. Department of Homeland Security, compromising the security of these devices would require a highly complex set of circumstances. 
Does this mean I should have my pacemaker removed?
No, preventative replacement is not necessary or recommended. Your pacemaker remains fully effective for providing pacing, as designed.
Should I continue to use my home monitor?
Yes, you should continue to use your Merlin@home™ device as it allows your physician to more frequently receive, assess, and monitor your device’s function.
What are the risks associated with the Getting the pacemaker firmware update?
We are anticipating the update will occur as planned. However, as with any firmware update, there is a very low rate of malfunction resulting from the update. We encourage you to discuss the risks and benefits of receiving the update with your doctor.
What you need to do if you decide to get a firmware update
- Please read this patient guide to learn more about the pacemaker firmware update, Abbott’s cybersecurity protocols, and protections that are already in place for our devices.
- As always, you should discuss the risks and benefits of any medical procedure with your doctor.
- If you have any further questions about the pacemaker firmware update, please contact our dedicated hotline at 1-800-722-3774 (U.S.).
For additional information on Abbott’s cybersecurity protocols, and protections that are already in place for our devices, please read our commitment to cybersecurity
Patient Guide FAQ: New Pacemaker Firmware Update - August 2017 (69kb)