# China NMPA Product Recall - Cryoablation device

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-cryocath-lp/4d608329-4ca2-4503-a36c-07712e7ef0d1/
Source feed: China

> China NMPA product recall for Cryoablation device by Medtronic CryoCath LP. published September 10, 2015. Recall level: . Medtronic CryoCath LP. initiated a voluntary recall of its Cryoablation Device (Model 106E2) due to 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic CryoCath LP. recalls cryoablation devices.
- Company Name: Medtronic CryoCath LP.
- Publication Date: 2015-09-10
- Product Name: Cryoablation device
- Recall Reason: Medtronic has identified a performance issue with the USB storage element for the aforementioned serial number used in the cryoablation device (model 106E2). This issue may affect the completion of the procedure if the user is unable to interpret system prompts.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic CryoCath LP.
- Summary: Medtronic CryoCath LP. initiated a voluntary recall of its Cryoablation Device (Model 106E2) due to a performance issue with the USB memory component. This issue, identified in specific serial numbers (N7785-N7787, N7763-N7784), could impair a user's ability to interpret system prompts, potentially impacting the successful completion of medical procedures. As of the report date, August 28, 2015, no patient injuries related to this defect had been reported. The recall was processed under the regulatory oversight of China's National Medical Products Administration (NMPA), formerly CFDA, which published the notice on September 10, 2015. Medtronic (Shanghai) Management Co., Ltd., the distributor, confirmed that while 25 affected units were imported, none were sold within China. As a required action, Medtronic engineers are replacing and testing the faulty USB components in their inventory to ensure all products meet required standards. Furthermore, the NMPA requested its regional food and drug administrations to enhance supervision of similar products, demonstrating a proactive approach to product safety.

Company: https://www.globalkeysolutions.net/companies/medtronic-cryocath-lp/6b6c18c8-e0f9-4be3-b790-4506bb0e58c3/