# China NMPA Product Recall - Star-shaped magnetoelectric dual-positioning mapping catheter PentaRay NAV eco High-Density Mapping Catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/biosense-webster-inc/aa1ed4bb-22a4-4abd-857a-3b5da5092018/
Source feed: China

> China NMPA product recall for Star-shaped magnetoelectric dual-positioning mapping catheter PentaRay NAV eco High-Density Mapping Catheter by Biosense Webster Inc. published May 18, 2020. Recall level: Level 2 Recall. On May 18, 2020, the National Medical Products Administration (NMPA) published a voluntary Class II 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its star-shaped magnetoelectric dual-positioning mapping catheter.
- Company Name: Biosense Webster Inc.
- Publication Date: 2020-05-18
- Product Name: Star-shaped magnetoelectric dual-positioning mapping catheter PentaRay NAV eco High-Density Mapping Catheter
- Recall Level: Level 2 Recall
- Recall Reason: If a catheter becomes trapped in a valvular structure during ventricular manipulation, surgical intervention is required to remove the catheter.
- Discovering Company: Biosense Webster, Inc.
- Manufacturing Company: Biosense Webster Inc.
- Summary: On May 18, 2020, the National Medical Products Administration (NMPA) published a voluntary Class II recall initiated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., specifically involving its subsidiary Biosense Webster, Inc. The recall concerns the PentaRay NAV eco High-Density Mapping Catheter (Registration Certificate No.: 20153772145). The core issue prompting this action stems from three global complaints reported in 2019 from Switzerland, the USA, and Australia. These complaints described instances where the catheter became lodged in valve structures during ventricular electroanatomical mapping procedures, necessitating surgical intervention for its removal. While the global incidence of this problem is noted as approximately 0.0008%, the severity of requiring surgery highlights a critical safety concern. A key contributing factor to the recall is an inadequacy in the product's Instructions For Use (IFU). Although valve injury is listed as a potential complication, the IFU did not explicitly mention the possibility or necessity of surgical removal if the catheter became stuck. This omission failed to adequately inform medical professionals of a significant potential risk and a subsequent required action. In response to these findings and to ensure patient safety, Biosense Webster, Inc. voluntarily initiated the Class II recall. While no adverse events or complaints related to this specific recall have been reported in China to date, the company is proactively addressing the identified safety risk under the oversight of the NMPA. The required action is the retrieval of all affected units of the PentaRay NAV eco High-Density Mapping Catheter.

Company: https://www.globalkeysolutions.net/companies/biosense-webster-inc/1e41796e-2ddf-4c5f-ba8b-efc71a994f80/