China NMPA Product Recall - Pulse Generator implantable cardiac pacemaker

St. Jude Medical Cardiac Rhythm Management Division has initiated a voluntary Class I recall for specific models of its implantable pacemakers, known as Pulse Generators. This significant regulatory action, reported on May 26, 2021, by Abbott Medical Products (Shanghai) Co., Ltd., and overseen by China's National Medical Products Administration (NMPA), addresses a critical electrical fault issue. The identified defect affects particular batches of these vital medical devices, which are registered under certificate numbers 20153120178, 20153121881, and 20183120455. A Class I recall is the most serious type, indicating that there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death. Consequently, St. Jude Medical is actively withdrawing the affected implantable pacemakers from the market. This voluntary recall aims to mitigate potential risks to patients reliant on these devices for cardiac rhythm management. The document specifies that comprehensive details regarding the impacted models, specifications, and batch numbers are provided in the attached Medical Device Recall Event Report Form. The provided information does not include any specific inspection dates related to this recall event.