China NMPA Product Recall - PTA dilation catheter (trade name: PowerCross)

Manufacturer Ev3 Inc. initiated a voluntary recall for its PowerCross PTA Dilatation Catheter (NMPA registration CFDA (Imported) 2012 No. 3770813 (Revised)) following the discovery of a manufacturing defect. Reported to the National Medical Products Administration (NMPA) by Covidien International Trading (Shanghai) Co., Ltd. on November 28, 2016, this action addresses a significant issue where the catheter’s outer shaft was squeezed and deformed at the proximal connection of the balloon.

Routine product inspections revealed that this deformation caused a narrowing of the internal lumen, potentially leading to critical failures such as the balloon not inflating, slowly deflating, or failing to deflate after inflation. An investigation traced the root cause to a new operator who failed to follow standard operating procedures (MP-703589), incorrectly inserting the product too far into a pleating and folding machine during manufacturing.

While Ev3 Inc. undertook the global voluntary recall for affected batches under NMPA oversight, the company confirmed that none of the defective products were imported into or sold within China. Consequently, no specific product retrieval or corrective actions were required in the Chinese market. However, provincial regulatory bodies were requested to enhance their supervision of similar products.