ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Reported: November 5, 2014 Initiated: October 19, 2014 #Z-0139-2015
Product Description
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Reason for Recall
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
Details
- Recalling Firm
- Biosense Webster, Inc.
- Units Affected
- 173,329 units total (21,812 units in US)
- Distribution
- Nationwide Distribution
- Location
- Irwindale, CA
Frequently Asked Questions
What product was recalled? ▼
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.. Recalled by Biosense Webster, Inc.. Units affected: 173,329 units total (21,812 units in US).
Why was this product recalled? ▼
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2014. Severity: Moderate. Recall number: Z-0139-2015.
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