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

Source: https://www.globalkeysolutions.net/records/china_product_recall/bard-peripheral-vascular-inc/881cf334-114b-4fa5-bcd7-06f56ffe9007/
Source feed: China

> China NMPA product recall for PTA balloon dilation catheter (trade name: Bard Rival) by Bard Peripheral Vascular, Inc. published July 06, 2015. Recall level: . Bard Peripheral Vascular, Inc. initiated a voluntary recall of its Bard Rival PTA Balloon Dilatation

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bard Peripheral Vascular, Inc. is recalling its PTA balloon dilation catheter (trade name: Bard Rival).
- Company Name: Bard Peripheral Vascular, Inc.
- Publication Date: 2015-07-06
- Product Name: PTA balloon dilation catheter (trade name: Bard Rival)
- Recall Reason: The compliance chart for a 7mm PTA balloon dilatation catheter indicates that inserting a 6mm PTA balloon dilatation catheter is incorrect. The 7mm compliance chart shows a burst pressure of 14 ATM, but for model RV135610, the burst pressure is 12 ATM. Therefore, over-dilation of the balloon could lead to occlusion or damage to the prosthetic vessel after a non-autogenous arteriovenous fistula procedure.
- Discovering Company: Bard Medical Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Bard Peripheral Vascular, Inc.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/bard-peripheral-vascular-inc/12056f40-c9c7-45e9-b305-900ec162d183/