Abbott is recalling 61,973 Assurity and Endurity pacemakers from the U.S. after learning that electrical shorts can cause problems including reduced battery life.
The fault, which stems from moisture ingress, could prevent the devices from delivering pacing, causing an irregular heartbeat and shortness of breath. Abbott has received reports of 135 injuries and no deaths.
FDA categorized the recall as a Class I event Thursday in light of the potential for the fault to cause serious injuries or death.
Abbott sent out a safety notification about the issue in March. At that time, Abbott had seen a 0.049% rate of malfunctions among devices manufactured on specific equipment from 2015 to 2018. The FDA recall covers devices distributed as late as February 2019. Abbott determined the problem was caused by the incomplete mixing of epoxy during manufacturing, which allowed moisture into the pulse generator header of some devices.
The manufacturing process is no longer in use but devices that may suffer from the fault could still be in use. To mitigate the risk, Abbott asked healthcare professionals to follow certain guidelines when treating patients who have one of the affected Assurity and Endurity pacemakers.
Abbott is not recommending the precautionary replacement of generators given "the very low rate of occurrence, and the low potential for patient harm when prompt replacement is performed following an unexpected [Elective Replacement Indicator (ERI)/End of Service (EOS)] alert." Rather, the company is advising that battery voltage is monitored during routine follow-up.
In a statement to MedTech Dive, a company spokesman also suggested the FDA's 'recall' terminology "may cause some confusion" noting "there is no recommendation for replacing the device if there is no evidence of the issue."
Between routine checks, Abbott is recommending that healthcare professionals monitor patients using its Merlin.net patient care network when possible. Abbott said ERI and EOS alerts are currently monitored daily. The 135 fault reports include 21 devices that reached ERI earlier than expected. The average gap from ERI to EOS was 17 days.
That shortened window between ERI and EOS is one of several consequences of the fault identified by Abbott. Other devices have suffered from loss of telemetry and loss of pacing. FDA listed slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness and discomfort as potential clinical consequences of the problem.
Abbott acquired the pacemakers as part of its 2017 takeover of St. Jude Medical. The affected devices were manufactured on either side of the $25 billion acquisition.
This story has been updated to include an additional statement from Abbott.