Biosense Webster recalls CARTO VIZIGO 8.:5F Bi-Directional Guiding Sheaths with water damage risk. Compromised sterile barrier may cause infection. Affected units have specific UDI-DI and lot numbers.
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.
Biosense Webster is recalling CARTO VIZIGO 8.5F Bi-Directional Guiding Sheaths that may have water damage, risking infection due to a compromised sterile barrier. This is a serious safety issue for medical procedures involving heart catheters.
Water damage to the sheath's packaging may have broken the sterile barrier, allowing bacteria to enter the product. This could lead to infections during heart catheter procedures if the sheath is used without proper sterility.
Healthcare professionals using the sheath for heart catheter procedures are most at risk. Patients undergoing these procedures could be affected if the sheath is used with a compromised sterile barrier.
Check for the UDI-DI number 10846835016253 and lot number 00002001 on the sheath packaging. The sheath is used to introduce cardiovascular catheters into the heart.
Look for the UDI-DI number 10846835016253 and lot number 00002001 on the sheath packaging.
The recall indicates potential water damage that could compromise the sterile barrier, so it is not safe to use without checking the packaging details.
Check the packaging for the UDI-DI number 10846835016253 and lot number 00002001. If you have these details, contact Biosense Webster for guidance.
The recall states that water damage may have affected the sterile barrier, so it is not safe to use without verifying the packaging details.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-1677-2022 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-1677-2022 from Biosense Webster. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
