# China NMPA Product Recall - Intra-aortic balloon counterpulsation pump (trade names: AutoCAT 2, AutoCAT 2 WAVE)

Source: https://www.globalkeysolutions.net/records/china_product_recall/arrow-international-inc/0ce01104-919f-4bdf-b496-4d6853ca8084/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation pump (trade names: AutoCAT 2, AutoCAT 2 WAVE) by Arrow International Inc. published June 18, 2020. Recall level: Level 1. Arrow International, Inc. initiated a voluntary recall of its Intra-Aortic Balloon Counterpulsation 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Arrow International, Inc. is voluntarily recalling its intra-aortic balloon pumps (trade names: AutoCAT 2, AutoCAT 2 WAVE).
- Company Name: Arrow International Inc.
- Publication Date: 2020-06-18
- Product Name: Intra-aortic balloon counterpulsation pump (trade names: AutoCAT 2, AutoCAT 2 WAVE)
- Recall Level: Level 1
- Recall Reason: The product in question may have a component in the IABP that is susceptible to vibration failure, potentially leading to a sudden shutdown or failure to start the IABP.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Arrow International Inc.
- Summary: Arrow International, Inc. initiated a voluntary recall of its Intra-Aortic Balloon Counterpulsation Pumps (IABPs), specifically the AutoCAT 2 and AutoCAT 2 WAVE models. This significant action, reported on June 18, 2020, and overseen by the National Medical Products Administration (NMPA) in China, addresses a critical product defect.The primary issue identified is that a component within the IABPs is susceptible to vibration failure. This flaw could lead to the sudden malfunction of the device or prevent it from starting, posing a serious risk to patient safety given the life-sustaining function of these pumps. Telefel Medical Devices Trading (Shanghai) Co., Ltd. communicated these concerns.Arrow International implemented a Level 1 recall, which is the most serious classification, indicating a reasonable probability that using or being exposed to the affected product could cause serious adverse health consequences or death. The recall encompasses specific products identified by their registration certificates (e.g., 20153211603, 2015308160, 20113211652) and batch numbers, detailed in an accompanying Medical Device Recall Event Report Form. This measure aims to prevent potential harm by removing affected devices from circulation.

Company: https://www.globalkeysolutions.net/companies/arrow-international-inc/8820e141-5ce7-4e2d-844a-672ff4232c9c/