Class II — Biosense Webster, Inc.
| 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 | Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. |
| Product | LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems. |
| Quantity | 464 units |
| Distribution | Nationwide Distribution |
| Initiated | 2015-02-25 |
| Classified | 2015-03-03 |
| Terminated | 2015-10-16 |
| Recall number | Z-1242-2015 |
| 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, Inc. (Z-1242-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70590/
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