FDA-Device2015-05-06Class II
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
Biosense Webster, Inc.
Hazard
The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
Sold states
US nationwide distribution.
Affected count
503 units
Manufactured in
15715 Arrow Hwy, Irwindale, CA, United States
Products
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1525-2015Don't want to check this manually?
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