# China NMPA Product Recall - Balloon dilation catheter (model 8012020D)

Source: https://www.globalkeysolutions.net/records/china_product_recall/cordis-europa-nv/6dea1a74-34d6-4fc4-955f-af68a712108c/
Source feed: China

> China NMPA product recall for Balloon dilation catheter (model 8012020D) by Cordis Europa N.V. published July 11, 2012. Recall level: . Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary recall of its Balloon D

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is recalling its balloon dilation catheter (model 8012020D).
- Company Name: Cordis Europa N.V.
- Publication Date: 2012-07-11
- Product Name: Balloon dilation catheter (model 8012020D)
- Recall Reason: The balloon dilation catheter with batch number 15437344 may have problems such as "slow contraction" or "failure to contract".
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Cordis Europa N.V.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary recall of its Balloon Dilatation Catheter (Model 8012020D, Batch Number 15437344), manufactured by Cordis Europa N.V. The recall, reported to the National Medical Products Administration (NMPA) in June 2012 and publicly announced in July 2012, addresses critical performance issues. The primary concern is the potential for the device to experience "slow contraction" or "failure to contraction," which could compromise its effectiveness in dilating narrowed coronary arteries and improving myocardial perfusion. While no specific inspection dates were provided, the company self-identified the issue. The regulatory framework for this action falls under the NMPA's oversight for medical device safety. In response, Johnson & Johnson has taken immediate actions: isolating all affected warehouse inventory and ceasing further shipments, and notifying affected distributors and users to stop selling or using the products and to facilitate their return. The NMPA has further directed regional food and drug administrations to strengthen their supervision of this recall process.

Company: https://www.globalkeysolutions.net/companies/cordis-europa-nv/9be3816a-7a83-4469-a733-b19dfb02086c/