NMPA Announcement | Import, Distribution and Use of Eurocor Tech GmbH's Paclitaxel-eluting PTA Balloon Catheter Suspended

The National Medical Products Administration (NMPA) issued Announcement No. 73 of 2026 on August 3, 2026, regarding the suspension of import, distribution, and use of paclitaxel-eluting PTA balloon catheters manufactured by Eurocor Tech GmbH (Germany).

NMPA conducted a remote inspection of Eurocor Tech GmbH, covering its paclitaxel-eluting PTA balloon catheter (Registration No.: National Medical Device Import Registration No. 20233030193). The inspection revealed deficiencies in the company's quality management system regarding product inspection and release review processes, posing quality and safety risks. The overall assessment concluded that the company "does not comply with China's Medical Device Production Quality Management Standards."

To ensure the safety of medical devices for public use, and in accordance with the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Production, NMPA has decided to suspend, effective immediately, the import, distribution, and use of Eurocor Tech GmbH's paclitaxel-eluting PTA balloon catheters.

Product Information:

The product is a paclitaxel-eluting PTA balloon catheter (FREEWAY™035), consisting of a PTA balloon, catheter shaft, hydrophilic coating, etc. The balloon surface is coated with 3 μg of paclitaxel per mm². The product is ethylene oxide sterilized, for single use, with a shelf life of 2 years. The registered address and manufacturing address are both at In den Dauen 6a, Bonn, Germany, with the local agent being Shanghai Micro Medical Devices Co., Ltd.

The Center for Food and Drug Inspection of NMPA (CFDI) officially issued the Notice of Results of Overseas Remote Inspection on Imported Medical Devices for this product on July 30, 2026, with a copy furnished to the registration agent.

Reminder: All medical institutions and distribution enterprises are required to strictly comply with this announcement and immediately cease the import, distribution, and use of the above-mentioned products. The public is encouraged to report any related violations to local drug regulatory authorities.