FDA-Device2022-09-14Class II
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Biosense Webster, Inc.
Hazard
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.
Sold states
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.
Affected count
98
Manufactured in
15715 Arrow Hwy, N/A, Irwindale, CA, United States
Products
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1677-2022Don't want to check this manually?
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