Z-2880-2020Class II

CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module -

Name: Z-2880-2020 CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module -
Creator: Biosense Webster (israel), Ltd.
Published: 2020-06-22
License: https://open.fda.gov/license/

Biosense Webster (Israel), Ltd. / initiated 2020-06-22 / Terminated / root cause: software

FDA source

Biosense Webster (israel), Ltd. began a recall of CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac... on 2020-06-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2880-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-22
Posted: 2020-08-24
Terminated: 2022-01-06
Recalling firm: Biosense Webster (Israel), Ltd.
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 during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On 06/22/2020, the firm notified affected US customers via mail of a hospital letter, "URGENT Medical Device Correction", which indicates the following: This product is not being removed from the market and does not need to be returned. A software service pack will be provided by the firm. Your representative will notify you when it is available and will arrange for installation of the service pack. In the meantime, the firm has identified certain mitigations preventing the issue from occurring: If your system is equipped with the VISITAG SURPOINT Module License: - Always enable the VISITAG SURPOINT Module and ensure that the External Processing Unit (EPU) is connected before starting a case. - When using review mode, ensure that the EPU is connected before entering the study and verify that a green connection indication is present on the screen. - When CARTO VISITAG recalculation was performed without the VISITAG SURPOINT Module enabled, recalculate the CARTO VISITAG results with the VISITAG SURPOINT Module by physically reconnecting the EPU, then exit and continue the study and verify that a green connection indication is present on the screen. If your system is not equipped with a VISITAG SURPOINT Module License: - Avoid triggering CARTO VISITAG recalculations as much as possible. - During the procedure consider applying a manual tag for each ablation location by acquiring an ablation point in addition to the CARTO VISITAG Module marking the ablation locations. - If a CARTO VISITAG tag disappears, the CARTO 3 system will still provide an indication of ablation at this location for the manually acquired points. - During offline review of a previous study, be aware that some CARTO VISITAG tags may have disappeared. For next steps, 1. Please review this letter carefully and share it with anyone in your facility that needs to be informed. 2. Please complete, sign, and return the Business Reply Form to the fim via email. The firm notif
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI *Three (3) U.S. government consignees. The countries of Australia, Austria, Belgium, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Portugal, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2880-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2880-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24

Product code DQK

K191660Class IICARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. / cleared 2019-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)