Outcomes Before and After the Recall of a Heart Failure Pacemaker.

Importance: Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively.

Objectives: To determine if the manufacturer's recommendations following the recall of a medical device were timely and complete, the follow-up information and data provided to patients and physicians were adequate for managing patient care, and the actions taken by the US Food and Drug Administration (FDA) regarding the recall were appropriate.

Design, Setting, And Participants: This single-center retrospective case series included 90 of 448 patients who were implanted with a cardiac resynchronization therapy pacemaker at the Minneapolis Heart Institute from May 2003 through January 2011; this pacemaker was recalled in November 2015.