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

Source: https://www.globalkeysolutions.net/records/china_product_recall/biosense-webster-israel-ltd/ed8031ff-4567-4576-9c73-f08e76a0d482/
Source feed: China

> China NMPA product recall for Diagnostic/ablation adjustable bend-end catheter by Biosense Webster (Israel) Ltd. published July 23, 2021. Recall level: Level 2 Recall. On July 23, 2021, the National Medical Products Administration (NMPA) announced 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 diagnostic/ablation adjustable elbow catheter.
- Company Name: Biosense Webster (Israel) Ltd.
- Publication Date: 2021-07-23
- Product Name: Diagnostic/ablation adjustable bend-end catheter
- Recall Level: Level 2 Recall
- Recall Reason: There may be welding problems at the connection point of the head electrode shell.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Biosense Webster (Israel) Ltd.
- Summary: On July 23, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Biosense Webster (Israel) Ltd., reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall pertains to specific models and batches of diagnostic/ablation adjustable elbow catheters. The primary issue identified was a potential welding problem at the tip electrode housing connection of these catheters, which could lead to usage risks. It is important to note that the affected products were not distributed or sold to hospitals within China, thereby mitigating direct patient risk in the Chinese market from these particular recalled batches. This regulatory action, overseen by the NMPA and detailed via the Shanghai Municipal Drug Administration Website, classifies the recall as Class II, indicating a situation where the probability of serious adverse health consequences is remote. The required action for the company is the immediate voluntary recall to ensure the safety and quality of medical devices. Further detailed information regarding specific product models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form" attachment.

Company: https://www.globalkeysolutions.net/companies/biosense-webster-israel-ltd/c6e03d3c-ce6c-4b62-9949-4ac0373c5074/