FDAFDA · Food and drugs·Recall number Z-1617-2013
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Published July 10, 2013 · Recall initiated: June 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biosense Webster, Inc.
- Distributor
- Distributed in the states of MN, FL, and UT.
- Lot
- Lot # 15832314L
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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