20-Pole LASSO Nav Catheter Eco — Class II medical device recall Z-1617-2013
Terminated recall by Biosense Webster, Inc., reported 2013-07-10, distributed in FL, MN, UT. Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated ca
| Recall number | Z-1617-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2013-06-19 |
| Classified | 2013-06-28 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2014-02-07 |
| Distributed | FL, MN, UT |
| Quantity | 10 units |
| Lot numbers | 15832314L |
| Model numbers | D-1349-02S |
Product
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Reason for recall
Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.
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-1617-2013. 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.