The FDA has announced that Abbott is recalling more than 60,000 Assurity and Endurity implantable pacemakers due to a risk of moisture causing electrical shorts that lead to significant complications.
This is a Class I recall, which means using an affected device can lead to serious injury or death. The FDA has heard about 135 injuries due to this ongoing issue, but no deaths have been reported.
If moisture does cause Assurity or Endurity pacemakers to malfunction, it can lead to a loss of device pacing, battery problems, telemetry failures and other potential issues.
“If the device is unable to deliver pacing, patients may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness, or discomfort,” according to a statement from the FDA. “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.”
The pacemakers affected by this recall were all distributed from April 29, 2015, to Feb. 20, 2019. Abbott informed affected customers on March 15, noting that replacing the device is not required “if there is no evidence of the issue.” Clinicians are also asked to “remind patients of the importance of using remote monitoring.”