Abbott is recalling a subset of Assurity and Endurity pacemakers over the potential for moisture to get inside the device causing an electrical short that may lead to a loss of device pacing, telemetry failure, or errors in information and reduced battery life.
The US Food and Drug Administration (FDA) has classified this recall as class I, the most serious type, because of the potential for serious injury or death.
“If the device is unable to deliver pacing, patients may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness, or discomfort. Additionally, shorter battery life and device life may lead to an additional pacemaker replacement procedure sooner than expected. Finally, if the system does not relay accurate information via telemetry, medical providers may not know to provide treatment,” notes the recall notice posted on the FDA website May 13.
To date, there have been 135 complaints, 135 injuries, and no deaths reported for this issue.
The recall covers 61,973 Assurity and Endurity pacemakers distributed in the US from April 29, 2015 to February 20, 2019.
Abbott sent a safety notice to customers informing them of the issue and providing patient management guidelines.
For now, the company is not recommending replacing the device if there is no evidence of the issue, because of a low rate of occurrence and low potential for patient harm as long as a replacement is completed if the device issues an unexpected elective replacement indicator (ERI) or end of service (EOS) alert.
The company advises routine follow-up per standard of care and clinical protocol. This includes reviewing any device function impacts such as battery voltage or any unexpected change in battery consumption; evaluating the potential risk for patients who are pacemaker-dependent and unable to be reliably followed using remote monitoring; and prompt replacement for devices that reach ERI or EOS unexpectedly or experience a clinical impact.
When possible, the company advises monitoring patients using Abbott’s Merlin.net management system for patient monitoring to receive alerts between routine device checks.
For more information about this recall, contact Abbott Technical Support at 1-800-722-3774.
Healthcare providers can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.