FDA-Device2014-11-05Class II
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Biosense Webster, Inc.
Hazard
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
Sold states
Nationwide Distribution
Affected count
173,329 units total (21,812 units in US)
Manufactured in
15715 Arrow Hwy, N/A, Irwindale, CA, United States
Products
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0139-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief