China NMPA Product Recall - Aveir Leadless Pacemaker VR Implantable Leadless Pacemaker

Abbott Medical Products (Shanghai) Co., Ltd., in collaboration with its manufacturer Abbott Medical Products, initiated a voluntary Class II recall of its Aveir Leadless Pacemaker VR on April 25, 2024. This action, overseen by the National Medical Products Administration (NMPA), addresses a critical issue where the implantable device could unexpectedly transition into MRI mode or Emergency VVI (EVVI) mode. Such an unforeseen change in operational mode could potentially compromise the device's intended therapeutic function and patient safety. The Class II recall designation by the NMPA indicates a situation where the probability of serious adverse health consequences from the product is remote, or where adverse effects are temporary or medically reversible. The affected products are identifiable by National Medical Device Registration Certificate No. 20243120113. As part of the required actions, Abbott Medical has provided comprehensive details regarding specific product models, specifications, and batch numbers in a "Medical Device Recall Event Report Form." This recall highlights the company's dedication to product safety and regulatory adherence, alongside the NMPA's vital role in ensuring medical device integrity for public health.