Complications from prophylactic replacement of cardiac implantable electronic device generators in response to United States Food and Drug Administration recall: A systematic review and meta-analysis

Prophylactic replacement of recalled CIED generators is associated with a low mortality rate but nontrivial rates of other major complications similar to those reported when CIED generators are replaced for other reasons. Thus, when considering replacing a recalled CIED generator, known risks of elective generator replacement likely apply and can be weighed against risks associated with device failure.