# China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/telif-medical-devices-trading-shanghai-co-ltd/7cf62340-ab4a-423e-a8a9-f8b5a86727c9/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation pump by Telif Medical Devices Trading (Shanghai) Co., Ltd. published June 01, 2020. Recall level: Level 1 Recall. Terif Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class I recall of its Intra

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Telefel Medical Devices Trading (Shanghai) Co., Ltd. is voluntarily recalling its intra-aortic balloon counterpulsation pumps (IACPs), including the IACPs AutoCAT 2 and AutoCAT 2 WAVE.
- Company Name: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-06-01
- Product Name: Intra-aortic balloon counterpulsation pump
- Recall Level: Level 1 Recall
- Recall Reason: The product in question is affected by a component in the IABP that is susceptible to vibration failure, which can cause fretting wear, carbonization, and discoloration of the motor connector wiring. This may result in pump alarms displaying "System Error 3" and "High Baseline" on the IABP screen, and may cause the pump to suddenly stop operating or fail to start.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Summary: Terif Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class I recall of its Intra-Aortic Balloon Counterpulsation Pumps (IABP), specifically models AutoCAT 2 and AutoCAT 2 WAVE, as detailed in a recall notice issued on June 1, 2020, by the Shanghai Municipal Drug Administration. This action addresses a significant product defect where a critical component within the pump is prone to vibration-induced failure.
The identified issue involves micro-wear, carbonization, and discoloration of the motor connector wiring. This degradation can lead to the display of "System Error 3" and "High Baseline" alarms, potentially causing the pump to stop operating abruptly or fail to start altogether. While no injuries or patient complications directly linked to this specific defect have been reported, and devices have not stopped without displaying the preceding alarms, the potential for serious harm necessitates this high-level recall.
The recall is being managed under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, highlighting the stringent regulatory framework governing medical devices in China. The company is actively retrieving affected units to mitigate any risk to patient safety. Further details regarding specific product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/telif-medical-devices-trading-shanghai-co-ltd/c0fdb740-6e25-4782-94b0-a6f732669ee5/