The U.S. FDA has categorized a recall of Abbot pacemakers caused by a manufacturing process that allowed moisture into the devices as a Class I event; some devices containing the fault could still be in use, reports MedTech Dive.
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.
Read more on MedTechDive.