Abbott is recalling certain pacemakers that may short circuit because they can allow moisture inside, according to the FDA.
The recall covers 61,973 Assurity and Endurity pacemakers manufactured by St. Jude Medical and distributed from April 2015 to February 2019. (Abbott acquired St. Jude in 2017).
A small number of devices from that time frame have experienced problems when moisture got inside the device, the agency said. The moisture can cause an electrical short, which may lead to:
- A loss of device pacing.
- Telemetry failure or information errors.
- 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 cannot deliver pacing, patients may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness or discomfort, according to the FDA. Additionally, shorter battery life and device life may lead to a replacement procedure sooner than expected. Finally, if the system does not relay accurate information via telemetry, medical providers may not know to provide treatment.
There have been 135 complaints about the pacemakers, 135 injuries and no deaths reported for this issue, the agency said. The FDA has designated this as a Class I recall, saying the use of these devices may cause serious injury or death.
Abbott notified customers of the issue in a letter on March 15, 2021, and provided patient management guidelines, including:
- No recommendation for replacing the device if there is no evidence of the issue.
- Routine follow-up per standard of care and clinical protocol, to include:
- A review of any device function effects, 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 patient monitoring system to receive alerts between routine device checks.
- Remind patients of the importance of using remote monitoring.