CLASS II Device recall · Reported 5 Nov 2014 · FDA Enforcement Report

ThermoCool SmartTouch Navigation Catheters recalled by Biosense Webster

Biosense Webster is recalling ThermoCool SmartTouch Navigation Catheters, distributed nationwide in the US. The recall was initiated on 19 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)

Quantity recalled173,329 units total (21,812 units in US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0139-2015
FDA event ID: 69532
Recalling firm: Biosense Webster, Irwindale, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Oct 2014
FDA classified: 27 Oct 2014
Reported: 5 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

19 Oct 2014	Recall initiated by company
27 Oct 2014	Classified by FDA	+8 days
5 Nov 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is ThermoCool SmartTouch Navigation Catheters recalled?

Yes. Biosense Webster recalled ThermoCool SmartTouch Navigation Catheters on 19 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0139-2015.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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