Biosense Webster, Inc. CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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