CARTO 3 System — Class II medical device recall Z-2880-2020
Terminated recall by Biosense Webster (israel), Ltd., reported 2020-09-02, distributed nationwide. Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation s
| Recall number | Z-2880-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster (israel), Ltd., Yoqne'Am Illit, N/A, Israel |
| Recall initiated | 2020-06-22 |
| Classified | 2020-08-24 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2022-01-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CL, CN, CO, CZ, DE, DK, ES, FI, FR, GB, HK, HU, IE, IL, IT, JP, KR, LV, NL, NO, PL, PT, SE, SI, TW |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10846835000870 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2880-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.