Class II — Biosense Webster (israel), Ltd.
| Recalling firm | BIOSENSE WEBSTER, INC. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | N/A |
| 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, Ge… |
| Initiated | 2020-06-22 |
| Classified | 2020-08-24 |
| Terminated | 2022-01-06 |
| Recall number | Z-2880-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biosense Webster (israel), Ltd. (Z-2880-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85910/
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