China NMPA Product Recall - Wallstent stents (tracheobronchial stents and biliary stents) with Unistep Plus delivery system.

Boston Scientific initiated a voluntary recall in 2011 for certain Wallstent stents, including tracheobronchial and biliary stents with the Unistep Plus delivery system. This action stemmed from concerns raised by the U.S. FDA in 2006 regarding the product's instructions for use. The primary issue involved the indication for benign bronchial lesions, specifically the statement "can be used for benign lesions after all elective treatments have failed." The FDA questioned this due to the potential for serious complications in patients with benign lesions who use metallic tracheal stents, as these stents, once implanted for longer periods, could preclude subsequent alternative treatments like surgery or silicone stent placement. Under the U.S. regulatory framework, Boston Scientific undertook a significant field corrective action within the United States and its territories. The required action was to clarify and reiterate to customers that Wallstent stents are not currently approved by the U.S. FDA for the treatment of benign bronchial lesions. Importantly, Boston Scientific stated that this recall did not involve the Chinese market. The National Medical Products Administration (NMPA) reported on this U.S. recall, requesting relevant Chinese food and drug administration departments to supervise products of this type.