# China NMPA Product Recall - Saline infusion microelectrode ablation catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/646dbd03-21e5-4176-8cef-52a6f8c52739/
Source feed: China

> China NMPA product recall for Saline infusion microelectrode ablation catheter by Boston Scientific Corporation published December 13, 2018. Recall level: Level 3. Boston Scientific Corporation voluntarily initiated a Class III recall for its Saline Irrigation Mic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific Corporation voluntarily recalls saline-infused microelectrode ablation catheters.
- Company Name: Boston Scientific Corporation
- Publication Date: 2018-12-13
- Product Name: Saline infusion microelectrode ablation catheter
- Recall Level: Level 3
- Recall Reason: Because of minor changes in the material composition of a cooling cavity assembly involved in the product, primarily changes in pigmentation, but these changes were not reflected in the Boston Scientific filings submitted in Japan.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific Corporation voluntarily initiated a Class III recall for its Saline Irrigation Microelectrode Ablation Catheter (IntellaTip MiFi Open-Irrigated Ablation Catheter) as reported to China's National Medical Products Administration (NMPA) on December 13, 2018, with the recall report dated December 5, 2018. The recall stems from a minor change in the material composition of a cooling lumen assembly, specifically pigment variations, which were not reflected in the company's regulatory filings in Japan, where the recall originated. Although a material change occurred, Boston Scientific determined that this alteration does not pose a foreseeable risk to patient safety, nor does it affect product performance, with the product still meeting all quality specifications. The regulatory framework involved the submission of a Medical Device Recall Event Report Form to the NMPA. Crucially, the affected product batches were sold exclusively in Japan, meaning no units were distributed in China. Consequently, Boston Scientific International Medical Trade (Shanghai) Co., Ltd. is not required to take further recall actions within China beyond the initial NMPA reporting, and will not submit additional investigative reports or recall plans in the region.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/