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Recall Observatory FDA recall evidence

Device product

ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

Z-0139-2015

October 19, 2014

Class II

Product summary

Firm
Biosense Webster, Inc.
Event
Event 69532
Status
Terminated
Classification
Class II
Quantity
173,329 units total (21,812 units in US)
Official record key
device-enforcement:Z-0139-2015

Official wording

Reason: The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.

Code information: Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.