LASSO NAV Duo Loop eco Catheters — Class II medical device recall Z-1242-2015
Terminated recall by Biosense Webster, Inc., reported 2015-03-11, distributed nationwide. Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting
| Recall number | Z-1242-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2015-02-25 |
| Classified | 2015-03-03 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2015-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 464 units |
| Model numbers | D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06 |
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.
Reason for recall
Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
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-1242-2015. 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.