FDA Device recall Z-2880-2020
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac…
- FDA Device
- Class II
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II 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… by Biosense Webster Israel, citing 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 extremel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2880-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-22 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biosense Webster Israel |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2880-2020%22
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