May 14, 2021 — Abbott is recalling a subset of Assurity and Endurity pacemakers built using specific manufacturing equipment distributed from April 2015 to February 2019, because a small number of devices from that time frame have experienced problems when moisture is able to get inside the device.
There have been 135 complaints and 135 injuries, but no deaths reported for this issue, according to the FDA.
The company issued a letter March 15, 2021 to customers informing them of the issue and providing patient management guidelines. The FDA issued a public notice on this recall May 13.
Abbott said moisture can cause an electrical short, that may lead to:
• A loss of device pacing.
• Telemetry failure or errors in information
• Early and fast battery drain
• Less time between the first battery depletion warning (elective replacement indicator or ERI) and the device’s end of service (EOS)
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.
Abbott's patient management guidelines including:
• No recommendation for replacing the device if there is no evidence of the issue, due to a low rate of occurrence and low potential for patient harm as long as a replacement is completed if the device issues an unexpected ERI/EOS alert.
• Routine follow-up per standard of care and clinical protocol, to include:
• A review of 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.
• Prompt replacement for devices that reach ERI or EOS unexpectedly or experience a clinical impact.
• If possible, use Abbott’s Merlin.net patience management system for patient monitoring to receive alerts between routine device checks. Remind patients of the importance of using remote monitoring.
• Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Assurity and Endurity are implantable pacemakers that detect when the heart is beating too slowly (bradycardia) and then send signals to the heart to make it beat at the correct pace. These pacemakers can be used to provide pacing for one chamber of the heart or both chambers, based on the patient’s condition.