China NMPA Product Recall - balloon dilation catheter

Cordis Corporation initiated a Class II voluntary recall of specific batches of its balloon dilatation catheters, as reported by Cordis (Shanghai) Medical Devices Co., Ltd. on September 11, 2018, and published by the National Medical Products Administration (NMPA) on October 22, 2018. The recall stemmed from a critical quality issue where several models failed the catheter body bursting test. Investigation revealed that air bubbles formed during the shaping process of the catheter body and seat were the likely root cause, compromising the tube's strength. This defect posed potential risks including difficulties in balloon dilation or contraction, inability to maintain pressure during use, and possible surgery delays. In some cases, it could also lead to damage to healthy intima, vasospasm, ischemia, or necessitate additional interventional procedures. Cordis confirmed that patients who successfully completed surgery with the device were not at risk, and no customer complaints or adverse event reports related to this specific defect had been received globally. Under the NMPA's oversight, Cordis Corporation implemented immediate corrective actions to address the production process defect, ensuring future batches would not be affected. The recall involved 1700 units across five models, impacting distributors and users in the United States, Japan, Puerto Rico, Australia, Switzerland, Germany, France, Ireland, Iran, Italy, the Netherlands, and Portugal. Importantly, none of the affected product batches were imported into China, thus negating the need for a recall or notifications within the Chinese market.