Class 2 Device Recall CARTO VIZIGO 8.5F BiDirectional Guiding

• Date Initiated by Firm: June 29, 2022
• Create Date: September 02, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1677-2022
• Recall Event ID: 90647
• 510(K)Number: K170997
• Product Classification: Introducer, catheter - Product Code DYB
• Product: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
• Code Information: UDI-DI: 10846835016253, Lot Number: 00002001
• FEI Number: 3003113629
• Recalling Firm/ Manufacturer: Biosense Webster, Inc.; 15715 Arrow Hwy; Irwindale CA 91706-2006
• Manufacturer Reason for Recall: Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
• FDA Determined Cause: Material/Component Contamination
• Action: On 6/29/22, re call notices started being emailed and mailed to customers who were asked to do the following: 1) The notice should be forwarded to anyone in the facility that needs to be aware. 2) Identify affected devices, unbox devices, and destroy the devices. 3) Complete and return the Business Reply Form and send back the label on empty boxes to receive credit. 4) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel. 5) Maintain a copy of this communication where the product identified in this letter is located until all products have been destroyed. If you have additional questions about this letter, please email the recalling firm at OneMD-Field-Actions@its.jnj.com
• Quantity in Commerce: 98
• Distribution: US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DYB