# China NMPA Product Recall - AngioSculpt PTA Scoring Balloon Catheter 0.018/〃OTW

Source: https://www.globalkeysolutions.net/records/china_product_recall/angioscore/6a47cd88-a5e7-47a9-966c-c192ab6d72f3/
Source feed: China

> China NMPA product recall for AngioSculpt PTA Scoring Balloon Catheter 0.018/〃OTW by AngioScore published February 22, 2011. Recall level: . On February 22, 2011, the National Medical Products Administration (NMPA) issued an announcement reg

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: AngioScore recalls AngioSculpt PTA integrating balloon catheter.
- Company Name: AngioScore
- Publication Date: 2011-02-22
- Product Name: AngioSculpt PTA Scoring Balloon Catheter 0.018/〃OTW
- Discovering Company: AngioScore
- Manufacturing Company: AngioScore
- Summary: On February 22, 2011, the National Medical Products Administration (NMPA) issued an announcement regarding a significant product recall initiated by the medical device manufacturer, AngioScore. The recall specifically targets the AngioSculpt PTA Integrating Balloon Catheter, identified as the 0.018/〃OTW model, which is also known as a Scoring Balloon Catheter. This action was a voluntary recall undertaken by AngioScore, as reported directly by the company itself. The NMPA document, however, does not provide specific details concerning the root cause, particular main violations, or any identified product issues that led to this decision. Consequently, the precise reasons behind AngioScore's voluntary withdrawal of the device from the market remain unspecified in this communication. Additionally, the document does not mention any inspection dates by regulatory bodies related to this recall event. Operating within its mandate as China's primary regulatory authority for medical products, the NMPA's involvement in this matter falls under its broader regulatory framework for ensuring public health and safety. The primary required action stipulated in the NMPA's announcement is a directive for all provincial and autonomous region drug administrations to acknowledge and pay close attention to this recall. This measure underscores the NMPA's role in disseminating critical safety information and coordinating regulatory oversight across regional health administrations, despite the absence of disclosed specific non-compliance issues in this particular document. The emphasis is on collective awareness and vigilance concerning medical device quality and post-market surveillance.

Company: https://www.globalkeysolutions.net/companies/angioscore/7b4d14ce-5a9a-4445-87f5-70cb6e14ffee/