What Electrophysiologists Should Know about Cardiac Implantable Electronic Device Recalls

From 2003-2023, manufacturers recalled 500 cardiac implantable electronic device (CIED) products, including pulse generators, leads, and programmers.1 Manufacturers of CIEDs have a legal responsibility to protect the public health under laws administered by the Food and Drug Administration (FDA)2. A CIED recall is a method of removing or correcting marketed products that violate these laws because the products either are defective or present a risk of death or injury.3
Source: Heart Rhythm - Category: Cardiology Authors: Source Type: research