Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Recalled by Biosense Webster, Inc. Due to Outside packaging for a device indicated for introducing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biosense Webster, Inc. directly.
Affected Products
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Quantity: 98
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biosense Webster, Inc.
Biosense Webster, Inc. has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report