Reported Nov 5, 2014 · Terminated
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602,…
Biosense Webster, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biosense Webster, Inc. · 15715 Arrow Hwy · Irwindale, CA · 91706-2006
Is this the product you have?
ThermoCool SmartTouch Navigation CathetersCatalog No. D132701D132702D132703D132704D132705D133601D133602D133603
- Lot codes and dates
- Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)
- Amount recalled
- 173,329 units total (21,812 units in US)
Where it was sold
- Nationwide
Why it was recalled
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
This product could cause temporary or reversible health problems — stop using it.
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