Biosense Webster recalls CARTO VIZIGO Bi-Directional Guiding Sheath (REF D128502) produced with a manufacturing mix-up during validation. Affected units may have been inadvertently mixed into main production. Contact for remedy details.
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Biosense Webster is recalling a specific model of cardiac sheath due to a manufacturing issue where units were accidentally mixed into production during validation. This could lead to potential safety risks if the sheath is used improperly.
The sheath was produced with a manufacturing mix-up during the validation phase, meaning some units were inadvertently mixed into the main production process. This could result in units that do not meet the required safety standards for cardiac procedures.
Medical professionals using the CARTO VIZIGO Bi-Directional Guiding Sheath for cardiac procedures are most at risk. Patients undergoing these procedures may be affected if the sheath is used without proper validation.
Check for the product reference number D128502 on the sheath. Affected units were produced with lot numbers 60000282. The sheath is used in cardiac procedures and has specific features like a hemostasis valve and radiopaque tip marker.
Look for the product reference number D128:502 and lot number 60000282 on the sheath.
The recall indicates a manufacturing mix-up during validation, so affected units may not meet safety standards. Consult the manufacturer for specific guidance.
Check for product reference number D128502 and lot number 60000282 on the sheath.
The recall does not specify a remedy, so contact Biosense Webster directly for further instructions.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-1290-2024 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-1290-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
