China NMPA Product Recall - PTA balloon dilation catheter (trade name: Bard Rival)

Bard Peripheral Vascular, Inc. initiated a voluntary recall of its Bard Rival PTA Balloon Dilatation Catheter (Model RV135610). This action was reported to the National Medical Products Administration (NMPA) on June 5, 2015, with the NMPA publishing the notice on July 6, 2015. The primary issue identified was the incorrect packaging of a "Compliance Chart" for a 7mm balloon, which indicated a Rated Balloon Pressure (RBP) of 14 ATM. The correct RBP for the 6mm RV135610 catheter is 12 ATM. This discrepancy creates a potential risk of over-expansion, which could damage native fistulae or grafts during procedures. However, a reliability analysis showed an estimated rupture risk of 0.01% (1 in 10,000) when inflated to 14 ATM, which is ten times lower than the FDA's acceptable threshold of 1 in 1,000. Under the NMPA's regulatory framework, the required actions include immediately stopping the distribution and sales of affected products and notifying users in the affected regions (USA, Latin America, Europe, and Australia). Notably, no units of the recalled product were sold or imported into China. Chinese food and drug administrations were advised to enhance their supervision and management efforts.