China NMPA Product Recall - PTA balloon dilation catheter

Bard Peripheral Vascular, Inc. initiated a voluntary recall of its CONQUEST PTA Balloon Dilatation Catheters, as reported by the National Medical Products Administration (NMPA) on May 4, 2015. This action was prompted by a manufacturing deviation where incorrect polytetrafluoroethylene (PTFE) dies were utilized during production. While Lot REYC1426 was definitively confirmed with this issue, other associated lots were conservatively included in the recall due to the potential for similar errors.

These catheters are intended for percutaneous endovascular angioplasty in femoral, iliac, and renal arteries, and for post-dilation of peripheral vascular stent grafts. The recall spans various regions, including the USA, Canada, Europe, Australia, Korea, and Taiwan. However, Bard Medical Technology (Shanghai) Co., Ltd. confirmed that none of the affected products were distributed or sold within China.

Under NMPA's guidance, the required actions for international markets involved an immediate halt to the distribution and use of the identified batches, followed by their quarantine. Although no direct impact on the Chinese market, Chinese regulatory bodies were instructed to oversee this product category. The recall emphasizes that these corrective measures are exclusively applicable to markets outside of China.