# China NMPA Product Recall - Venous sheath

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-lifesciences-llc/bc1549b2-bbe0-44ea-8c38-5f5eb0c99ab2/
Source feed: China

> China NMPA product recall for Venous sheath by Edwards Lifesciences LLC published May 07, 2019. Recall level: Level 3. Edwards Lifesciences LLC, in conjunction with its agent Edwards (Shanghai) Medical Supplies Co., Ltd

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edwards Lifesciences LLC initiates proactive recall of venous vascular sheaths.
- Company Name: Edwards Lifesciences LLC
- Publication Date: 2019-05-07
- Product Name: Venous sheath
- Recall Level: Level 3
- Recall Reason: This recall concerns a non-standard nylon disk within a venous sheath (model: 1355BF9). The undersized nylon disk may prevent the user from inserting the dilator into the sheath. If the dilator cannot pass through the sheath, it may cause a minor delay in the procedure due to the need for device replacement. Since the nylon disk is not intended to prevent leakage, its undersized size does not cause leakage.
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards Lifesciences LLC
- Summary: Edwards Lifesciences LLC, in conjunction with its agent Edwards (Shanghai) Medical Supplies Co., Ltd., executed a voluntary Class III recall of its Vein Vascular Sheath, specifically model 1355BF9. This action, reported to the National Medical Products Administration (NMPA) and published on May 7, 2019, addresses a manufacturing anomaly within the medical device. The core issue involves the nylon disk inside the venous sheath, which was found to have a non-compliant size. This dimensional discrepancy poses a potential challenge during clinical use, as healthcare professionals may encounter difficulty inserting the dilator into the vascular sheath. While this defect is not expected to cause product leakage or severe patient harm, it could necessitate device replacement during a procedure, leading to unforeseen delays for patients and medical staff. The recall, impacting regions including Europe, the Middle East, and Asia Pacific, was initiated to mitigate this functional impairment. The regulatory framework under which this recall operates is the NMPA's medical device oversight, given the product's registration under National Medical Device Registration Certificate 20163772634. The required action by the company is to remove the affected batches from distribution.

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