# China NMPA Product Recall - Floating Catheters (Thermodilution/Non-Thermodilution)

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-lifesciences-llc/d4067094-b78e-4810-93d3-f504dbd5b83a/
Source feed: China

> China NMPA product recall for Floating Catheters (Thermodilution/Non-Thermodilution) by Edwards Lifesciences LLC published March 14, 2023. Recall level: Level 2 Recall. Edwards Lifesciences LLC, in collaboration with its subsidiary Edwards (Shanghai) Medical Supplies C

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edwards Lifesciences LLC is voluntarily recalling its floating catheters.
- Company Name: Edwards Lifesciences LLC
- Publication Date: 2023-03-14
- Product Name: Floating Catheters (Thermodilution/Non-Thermodilution)
- Recall Level: Level 2 Recall
- Recall Reason: Catheter tip bending and hot wire error messages
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards Lifesciences LLC
- Summary: Edwards Lifesciences LLC, in collaboration with its subsidiary Edwards (Shanghai) Medical Supplies Co., Ltd., initiated a voluntary Class II recall of its Thermodilution/Non-Thermodilution Catheters. This action, reported on March 14, 2023, by the National Medical Products Administration (NMPA), was prompted by significant product issues observed in the field. The primary concerns identified were instances of catheter tip bending and the occurrence of "hot wire error messages" during use. These malfunctions pose potential risks to patient safety and product efficacy, necessitating immediate corrective measures. The affected devices, registered under National Medical Device Registration Certificate No. 20163074711, are subject to this recall to ensure compliance with quality and safety standards. A Class II recall signifies that the product may cause temporary or reversible health consequences, or that the probability of serious adverse health consequences is remote. Edwards Lifesciences LLC has taken responsibility for addressing these manufacturing or design deficiencies by initiating this recall. Further details regarding specific product models, specifications, and batch numbers are outlined in the accompanying "Medical Device Report Form" and "Medical Device Recall Event Report Form." The company is expected to implement corrective and preventive actions to prevent recurrence of these issues, upholding its commitment to patient safety and product integrity under the NMPA's regulatory oversight.

Company: https://www.globalkeysolutions.net/companies/edwards-lifesciences-llc/d78876e8-6a4a-49b4-8cb5-30579a7ed097/