# China NMPA Product Recall - Guide wire (brand name: Provia), Guide wire (brand name: Cougar)

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/17416c27-7ffd-4a65-bc72-e12808853a7b/
Source feed: China

> China NMPA product recall for Guide wire (brand name: Provia), Guide wire (brand name: Cougar) by Medtronic Inc. published December 13, 2013. Recall level: . Medtronic, Inc. initiated a voluntary global recall of specific interventional guidewires, including

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic, Inc. is recalling guidewires and guidewires.
- Company Name: Medtronic Inc.
- Publication Date: 2013-12-13
- Product Name: Guide wire (brand name: Provia), Guide wire (brand name: Cougar)
- Recall Reason: The PTFE (polytetrafluoroethylene) coating may detach from the guide wire.
- Discovering Company: Shanghai Municipal Food and Drug Administration
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic, Inc. initiated a voluntary global recall of specific interventional guidewires, including Provia (NMPA Registration No. 20133771007) and Cougar (NMPA Registration No. 20103771926) models. This recall, reported by the Shanghai Municipal Food and Drug Administration on December 2, 2013, and subsequently published by the National Medical Products Administration (NMPA) on December 13, 2013, was prompted by the potential for the polytetrafluoroethylene (PTFE) coating to detach from the guidewire. These guidewires are critical for introducing and positioning diagnostic or interventional devices in coronary and peripheral blood vessels. Though Medtronic China had not received complaints about this specific issue, the company acted proactively to address the identified defect.

Under the NMPA's regulatory oversight, Medtronic implemented a comprehensive corrective action plan. This involved immediately halting the sale of all potentially affected products and notifying global distributors to return recalled batches. Medtronic representatives personally contacted clinicians to deliver customer notification letters, instructing them to remove and isolate all potentially affected guidewires from inventory for return. Assistance was offered for replacement products, and users were required to complete a customer confirmation form. For affected products already in use, no further action was required, and standard treatment protocols were advised. The recall report from Medtronic (Shanghai) Management Co., Ltd. was dated November 19, 2013.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/