China NMPA Product Recall - Implantable cardioverter-defibrillator; Implantable resynchronization cardioverter-defibrillator

St. Jude Medical Supplies (Shanghai) Co., Ltd., under the National Medical Products Administration (NMPA) framework, initiated a Level I voluntary recall for specific implantable cardiac defibrillators (ICDs) and cardiac resynchronization defibrillators (CRT-Ds). Published on December 7, 2016, this recall addresses a significant issue of premature battery depletion in devices manufactured before May 23, 2015. The underlying cause is lithium-ion deposition forming crystal clusters within the battery, leading to internal short circuits. Globally, 841 out of 398,740 products (0.21%) exhibited this depletion, with 46 cases showing clear short circuits. In China, one suspected premature battery depletion complaint was reported among 1,510 units sold.Required actions include immediately discontinuing the implantation of affected, unused products. Physicians are instructed to follow up with patients who have implanted devices using standard procedures. Prophylactic device replacement is not recommended due to higher surgical complication rates compared to the risk of the battery issue. However, if a device displays an Emergency Reference Indication (ERI), immediate replacement is advised, as ERI triggers an alarm. Furthermore, physicians must reconfirm remote monitoring systems for patients using merlin@home to ensure uninterrupted care.