Biosense Webster recalls CARTO 3 System software version V7.1.80 due to rare risk of cardiac perforation from software defects during ablation procedures.
Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation.
Biosense Webster is recalling its CARTO 3 System software version V7.1.80 because a software defect might cause the system to miss tag sites during ablation procedures. This could lead to longer surgeries and, in extremely rare cases, cardiac perforation.
A software defect in version V7.1.80 may cause the system to miss tag sites during recalculation. This could lead to additional ablation sites being created, prolonging the procedure and, in extremely rare cases, causing cardiac perforation.
Patients undergoing cardiac electrophysiology procedures with the CARTO 3 System software version V7.1.80 are affected. Medical professionals using this specific software version are most at risk.
The recalled product is the CARTO 3 System with software version V7.1.80 and the CARTO VISITAG Module. All units sold with this specific software version are affected.
Verify the software version on your CARTO 3 System; if it is V7.1.80, it is affected.
The recall is for a software defect that may cause rare cardiac perforation in extremely rare circumstances during ablation procedures.
Check your software version; if it is V7.1.80, contact Biosense Webster for guidance.
The hazard is described as extremely rare, but the software defect could lead to additional ablation sites during procedures.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-2880-2020 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-2880-2020 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.
