# China NMPA Product Recall - Star-shaped magnetoelectric dual-positioning mapping catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/biosense-webster-inc/55fe86d3-efb1-471a-b4f5-c2228715d0de/
Source feed: China

> China NMPA product recall for Star-shaped magnetoelectric dual-positioning mapping catheter by Biosense Webster Inc. published July 06, 2016. Recall level: Level III. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a Class III recall for its Star-sha

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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: 2016-07-06
- Product Name: Star-shaped magnetoelectric dual-positioning mapping catheter
- Recall Level: Level III
- Recall Reason: Between January 2014 and March 2016, the manufacturer received four customer complaints regarding intraoperative entanglement of the PENTARAY® catheter in patients with implanted artificial heart valves. Excessive force applied to the entangled catheter could lead to partial dislodgement and embolism within the patient. The current product instructions state in the contraindications section that the PENTARAY® catheter should not be used in patients with implanted artificial heart valves: "This catheter may not be suitable for patients who cannot have implanted artificial heart valves." To prevent off-label use and the recurrence of such events, IFU has updated this contraindication to: "Do not use the PENTARAY® catheter in patients with implanted artificial heart valves." To date, no related complaints or adverse events have been received in China.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Biosense Webster Inc.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a Class III recall for its Star-shaped Magnetoelectric Dual-positioning Mapping Catheter (PENTARAY®) on July 6, 2016, under the National Medical Products Administration (NMPA) framework. This action followed four customer complaints between January 2014 and March 2016 from global markets, including Canada, China, and Japan, reporting catheter entanglement during surgery in patients with implanted artificial heart valves. Such entanglement could lead to excessive force, causing catheter detachment and potential embolism. While the original product instructions advised that the catheter "may not be suitable" for patients with artificial heart valves, this cautionary language proved insufficient to prevent off-label use. To mitigate future risks, Johnson & Johnson's corrective actions included updating the product's Instructions for Use (IFU) to a stronger, definitive contraindication: "Do not use the PENTARAY® catheter in patients with implanted artificial heart valves." Additionally, affected distributors and hospitals were notified. No product returns were required, and no related complaints or adverse events were reported in China at the time of the recall.

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