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.
Other recalls by Biosense Webster
- VARIPULSE Bi-Directional Ablation Catheter REF D141201
FDA Device · Class I · 2025-03-12 · Biosense Webster - CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibili…
FDA Device · Class II · 2024-03-20 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501
FDA Device · Class II · 2022-09-14 · Biosense Webster
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1242-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.