FDA Device recall Z-1242-2015
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
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of 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 by Biosense Webster, citing biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1242-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-25 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biosense Webster |
| Distribution | US |
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
Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
Identifiers
| code_info | All lots manufactured as of February 24, 2015 are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1242-2015%22
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