Abbott Assurance (pacemakers)

2021: Withdrawal of short-circuit pacemakers

In mid-May 2021, Abbott announced the recall of some pacemakers that are susceptible to short circuit due to the possibility of moisture entering the device.

The recall applies to 61973 Assurance and Endurance pacemakers manufactured by St. Jude Medical and distributed from April 2015 to February 2019 (Abbott acquired St. Jude in 2017).

Abbott Recalls Assurance and Endurance Short Circuit Pacemakers

The Food and Drug Administration (FDA) reported that ingress of moisture into devices released during a specified time period may result in:

• lack of a stimulation device;
• telemetry failure or information errors;
• early and fast battery discharge;
• reducing the time between the first battery discharge warning and the end of service of the device.

If the device cannot perform pacing, patients may experience slow or irregular heartbeats, fainting, shortness of breath, fatigue, dizziness or discomfort, the FDA reports. In addition, shorter battery and device life may result in an earlier replacement procedure than expected. Finally, if the system does not transmit accurate information through telemetry, health care providers will not be able to correctly prescribe a treatment plan.

Abbott notified users of defective pacemakers of the problem in a letter dated March 15, 2021 and provided guidance on patient management.

According to the FDA, a total of 135 complaints were received about pacemakers, 135 injuries and no deaths were recorded. The FDA designated the recall of the Assurance and Endurance devices as a Class I recall, saying the use of these devices could lead to serious injury or death.^[1]

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