Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. 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 i

U.S. FDA — Device Enforcement · United States · 2015-02-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1242-2015
Date of alert: 2015-02-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biosense Webster, Inc.
Product category: device
Product type: Devices

Reported risk: Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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