Medical Device Voluntary Recall Notice

On July 22, 2026, China’s National Medical Products Administration (NMPA) published an official notice regarding a voluntary recall initiated by Abbott Medical for its EnSite™ X EP System (Registration Certificate No. 20243070386). The recall is classified as Class III, the lowest risk level, indicating that the issue is unlikely to cause adverse health consequences.

The action was triggered by a report from Abbott Medical (Shanghai) Co., Ltd., stating that 39 affected EnSite X Surface Link connectors may generate an unexpected error message when the system is powered on and connected. The error reads: “Left Leg Electrode Module Data Error. Reinsert the Data Module and Re‑validate. If the problem persists, contact Abbott Technical Support.” Importantly, this message appears before the physician performs femoral artery puncture on the patient, thus it blocks the system verification step but does not pose any risk or harm to patients. In such cases, the recommended resolution is simply to replace the connector with a new one.

The affected product model is ENSITE-SRFLNK-01, with a total of 39 units involved. Their serial numbers are listed in the attached recall report form. A key point for the Chinese market: none of the impacted batches were ever imported or sold in China. Consequently, apart from notifying the NMPA as required, Abbott is taking no further corrective measures within the country.

This proactive recall demonstrates the company’s commitment to quality assurance and patient safety, even when no direct local impact exists.