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

Recall Z-1617-2013 — 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.

U.S. FDA — Device Enforcement · United States · 2013-06-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1617-2013
Date of alert
2013-06-19
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 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.
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.

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