The Recall Desk
SevereFDA (Devices)·Z-2880-2020·Announced 2020-09-02

Biosense Webster Recalls CARTO 3 System Software Due to Defect

Biosense Webster is recalling the CARTO 3 System software due to a defect that may cause tag sites to disappear, potentially leading to cardiac perforation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of cardiac perforation, which constitutes a significant injury risk under the severity rubric.

Plain-English summary

Biosense Webster (Israel), Ltd. is recalling the CARTO 3 System (Software Version V7.1.80) and the CARTO VISITAG Module. The recall covers all serial numbers of the product, which is used for catheter-based cardiac electrophysiological (EP) procedures to monitor heart electrical activity and catheter location.

The recall is being conducted because a software defect may cause tag sites to disappear during recalculation. This issue could lead to additional ablation sites, prolonging the procedure. In extremely rare circumstances, the defect may result in cardiac perforation.

The affected products were distributed worldwide, including nationwide distribution in the United States and to three U.S. government consignees. The recall also includes distribution to numerous international countries. Users of the system should contact the manufacturer for further instructions regarding the software defect.

The recalled product

Product
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location
Manufacturer
Biosense Webster (israel), Ltd.
Category
Medical Device — Cardiac Electrophysiology
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Related recalls

Same hazard · software defect

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