CLASS II Device recall · Reported 11 Mar 2015 · FDA Enforcement Report

Lasso NAV Duo Loop eco Catheters recalled by Biosense Webster

Biosense Webster is recalling Lasso NAV Duo Loop eco Catheters, distributed nationwide in the US. The recall was initiated on 25 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots manufactured as of February 24, 2015 are affected.

Quantity recalled464 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-1242-2015
FDA event ID: 70590
Recalling firm: Biosense Webster, Irwindale, CA
Classification: Class II
Status: Terminated
Recall initiated: 25 Feb 2015
FDA classified: 3 Mar 2015
Reported: 11 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

25 Feb 2015	Recall initiated by company
3 Mar 2015	Classified by FDA	+6 days
11 Mar 2015	Published in enforcement report	+8 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 is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.

Product as listed by the FDA

LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Lasso NAV Duo Loop eco Catheters recalled?

Yes. Biosense Webster recalled Lasso NAV Duo Loop eco Catheters on 25 Feb 2015. The recall is Class II and its status is Terminated. Recall number Z-1242-2015.

Why was it recalled?

Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.

Which lots are affected?

All lots manufactured as of February 24, 2015 are affected.

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.

More recalls from Biosense Webster

All 32

Reported	Class	Recall	Company	Reason	Where
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

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide