CLASS II Device recall · Reported 8 Nov 2017 · FDA Enforcement Report

Thermocool SF NAV Catheters recalled by Biosense Webster

Biosense Webster is recalling Thermocool SF NAV Catheters. The recall was initiated on 6 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes17637495L 17638389L 17639706L 17639707L 17639708L 17640039L 17640494L 17640952L 17640040L 17640742L 17640953L 17640041L 17640743L 17640954L 17640490L 17640744L 17643130L 17638118L 17638387L 17638388L

Quantity recalled329 units

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-0058-2018
FDA event ID: 78129
Recalling firm: Biosense Webster, Irwindale, CA
Classification: Class II
Status: Terminated
Recall initiated: 6 Sep 2017
FDA classified: 27 Oct 2017
Reported: 8 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Heart & Vascular Devices

Timeline

6 Sep 2017	Recall initiated by company
27 Oct 2017	Classified by FDA	+51 days
8 Nov 2017	Published in enforcement report	+12 days

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

Reason for recall

Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

Where it was distributed

US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China

Questions about this recall

Is Thermocool SF NAV Catheters recalled?

Yes. Biosense Webster recalled Thermocool SF NAV Catheters on 6 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-0058-2018.

Why was it recalled?

Which lots are affected?

17637495L 17638389L 17639706L 17639707L 17639708L 17640039L 17640494L 17640952L 17640040L 17640742L 17640953L 17640041L 17640743L 17640954L 17640490L 17640744L 17643130L 17638118L 17638387L 17638388L

Where was it sold?

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.

More recalls from Biosense Webster

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12 Mar 2025Device	CLASS I	Varipulse Bi-Directional Ablation Catheter recalled by Biosense Webster	Biosense Webster	Other	10 states
20 Mar 2024Device	CLASS II	Carto Vizigo Bi-Directional Guiding Sheath recalled by Biosense Webster	Biosense Webster	Other	Nationwide
12 Apr 2023Device	CLASS II	Carto Vizigo Bi-Directional Guiding Sheath, 5F(Medium) recalled	Biosense Webster	Labeling Errors	Nationwide
12 Apr 2023Device	CLASS II	Carto Vizigo Bi-Directional Guiding Sheath, 5F(Small) recalled	Biosense Webster	Labeling Errors	Nationwide
14 Sep 2022Device	CLASS II	Carto Vizigo 5F Bi-Directional Guiding Sheath recalled	Biosense Webster	Sterility	Nationwide

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