Johnson & Johnson's Impella Percutaneous Left Ventricular Assist Device Registration Terminated in China Amid Rising Domestic Competition

Within China’s current regulatory framework for the review and approval of medical devices, “termination of registration review” is typically triggered by the following two compliant scenarios:

The Applicant inPrior to the regulatory authority making a final administrative licensing decisionVoluntary Withdrawal ApplicationSubmission Documents;

After receiving the notice for supplementary materials issued by the drug regulatory authority, the applicant failed to complete the submission of the required corrective documents within the statutory one-year time limit, resulting in the reviewProgram terminated automatically。

Although this does not mean that the product is completely shut out of the Chinese market, it at least signifies that the timeline for the commercial launch of this medical device in China will be forced to be significantly delayed.

Meanwhile, similar productsForQaly's SynFlow®3.0pVAD andCore MedicalCorVadpVADs have all been commercialized.

Currently, no public information has disclosed the specific reasons for the termination of registration; however, the following information may provide some clues:

1. Safety Record: Multiple FDA Class I Recalls

• In March 2024, the U.S. Food and Drug Administration (FDA) issued a Class I recall—the most severe warning level for medical devices in the United States—for Impella heart pumps, indicating that use of the device could result in serious injury or death. The recall covered six models of Impella products worldwide due to the risk that the pump catheter might perforate the left ventricular wall during procedures, potentially leading to left ventricular perforation, free wall rupture, hypertension, inadequate blood supply, or even death. As of that time, 49 deaths and 129 cases of serious injury had been reported.

• Over the past year, Impella has undergone four Class I recalls. In May 2026, the FDA issued another early alert, highlighting a high-risk software bug in Impella’s automatic controller. Frequent safety issues,

This globally benchmarked regulatory action may be incorporated as a core consideration by the Center for Technical Evaluation of China’s National Medical Products Administration (NMPA). Johnson & Johnson Medical requires additional time to integrate the latest global safety amendments, labeling updates, and even hardware upgrade achievements into its localized submission materials, thereby avoiding the public relations and legal risks associated with direct rejection.

2. The Changing Landscape of the Chinese pVAD Market

• In December 2025, Core Medical’s percutaneous left ventricular assist device received regulatory approval, marking the first-ever breakthrough for domestically produced pVADs in China, and 2026 also becameChinese Domestic Enterprises'The Year One of pVAD。

• In June 2026, ForQaly’s SynFlow® 3.0 System was subsequently approved for market launch.

• According to industry statistics, more than 10 companies have already invested in the research and development of interventional artificial hearts, and 2026 is widely regarded by the industry as the “collective approval year” for pVADs.

In this context, for multinational medical device giants, the halo of being “the only FDA-approved product globally” is no longer sufficient to penetrate the Chinese market. Safety records, local clinical evidence, and price accessibility are becoming the new thresholds for market access.

Johnson & Johnson’s Impella Percutaneous Left Ventricular Assist Device System Terminates Registration in China, Marking Another “Waterloo” for the Multinational Medical Device Giant in the Chinese Market.

The impact of this event extends far beyond the gains or losses of a single company. It marks a shift in China’s medical device regulation from “follow-up review” to “independent assessment”—even global benchmark products must demonstrate their value with robust safety data and localized evidence. For domestic pVAD manufacturers accelerating their market presence, this represents a strategic window of opportunity worth seizing.