Boston Scientific Corporation: VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.

Hazard

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

Details from the source

Reason for recall: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan. Quantity: 14,724 Lot/code info: UDI-DI 00685447006121 Lot 35935598

UPC codes

00685447006121

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.