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Biosense Webster, Inc. recalls ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D
Recalled November 5, 2014 · FDA recall Z-0139-2015 · Biosense Webster
Hazard
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. · FDA Class II
Units
173,329 units total (21,812 units in US)
Sold at
Nationwide Distribution
Description
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
Product
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Manufacturer(s)
Biosense Webster, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →