FDA Class I Recall: Abbott Assurity and Endurity pacemakers for potential moisture ingress causing electrical short and reduced battery life

May 17, 2021

The Food & Drug Administration (FDA) announced Abbott (formally known as “St. Jude Medical”) is recalling a subset of Assurity and Endurity pacemakers built using specific manufacturing equipment, that were then distributed from April 2015 to Feb. 2019.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. There have been 135 complaints, 135 injuries, and no deaths reported for this issue.

A small number of devices from that time frame have experienced problems when moisture is able to get inside the device. The 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.

Recalled Product: Scalable Bradycardia Platform (SBP) Pacemakers: Assurity and Endurity

Distribution Dates: April 29, 2015 to Feb. 20, 2019

Devices Recalled in the U.S.: 61,973

Date Initiated by Firm: March 15, 2021

FDA has the recall.