CLASS II Device recall · Reported 6 May 2015 · FDA Enforcement Report

Webster HIS Catheter, 4 Pole Fixed Curve recalled by Biosense Webster

Biosense Webster is recalling Webster HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac, distributed nationwide in the US. The recall was initiated on 17 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 17147443M, 17177237M, 17196045M, 17142745M, 17176185M, 17191133M, 17177957M, 17162927M, 17163734M, 17159129M, 17157116M, 17144954M, 17192170M, 17192723M, 17173428M, 17174967M, 17174968M, 17194186M, 17194707M, 17153400M, 17154595M, 17176186M, 17142888M, 17167809M, 17167282M, 17158235M, 17159407M, 17151134M, 17154141M, 17176477M, 17176478M, 17172465M, 17145731M, 17146665M, 17172058M.

Quantity recalled503 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-1525-2015
FDA event ID: 71021
Recalling firm: Biosense Webster, Irwindale, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Apr 2015
FDA classified: 27 Apr 2015
Reported: 6 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

17 Apr 2015	Recall initiated by company
27 Apr 2015	Classified by FDA	+10 days
6 May 2015	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 Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.

Product as listed by the FDA

WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413

Where it was distributed

US nationwide distribution.

Nationwide

Questions about this recall

Is Webster HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac recalled?

Yes. Biosense Webster recalled Webster HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac on 17 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1525-2015.

Why was it recalled?

The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.

Which lots are affected?

Lot No. 17147443M, 17177237M, 17196045M, 17142745M, 17176185M, 17191133M, 17177957M, 17162927M, 17163734M, 17159129M, 17157116M, 17144954M, 17192170M, 17192723M, 17173428M, 17174967M, 17174968M, 17194186M, 17194707M, 17153400M, 17154595M, 17176186M, 17142888M, 17167809M, 17167282M, 17158235M, 17159407M, 17151134M, 17154141M, 17176477M, 17176478M, 17172465M, 17145731M, 17146665M, 17172058M.

Where was it sold?

US 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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