Recall StatusTerminated
Date Initiated2020-06-22
Date Terminated2022-01-06
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.
Firm 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
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.