# China NMPA Product Recall - Diagnostic/ablation adjustable bend-end catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-shanghai-medical-devices-co-ltd/eb127c95-c566-48ae-9573-39006cca45d2/
Source feed: China

> China NMPA product recall for Diagnostic/ablation adjustable bend-end catheter by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. published November 13, 2017. Recall level: Level 2 Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its diagnostic/ablation adjustable elbow catheter.
- Company Name: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2017-11-13
- Product Name: Diagnostic/ablation adjustable bend-end catheter
- Recall Level: Level 2 Recall
- Recall Reason: An increase in the number of alarms related to magnetic field distortion in the product display may lead to inaccurate catheter tip position information in the electrophysiological navigation system.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its diagnostic/ablation adjustable elbow catheters, as reported by the National Medical Products Administration (NMPA) on November 13, 2017. The recall was prompted by an observed increase in alarms indicating magnetic field distortion within the affected medical devices. This distortion poses a significant concern as it could lead to inaccurate catheter tip position information when used with electrophysiological navigation systems, potentially impacting patient safety and treatment efficacy. While specific inspection dates were not detailed, the company's proactive measure to voluntarily recall these devices falls under the regulatory oversight of the NMPA, which manages medical device safety. The required action involves the voluntary removal of the affected catheters from the market, with further specifics regarding product models and serial numbers provided in the associated "Medical Device Recall Event Report Form". This action underscores a commitment to product quality and patient safety within the established medical device regulatory framework.

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-shanghai-medical-devices-co-ltd/c552b533-9bb4-43a8-858a-e58faf1dd14e/