CLASS II Device recall · Reported 31 Mar 2021 · FDA Enforcement Report

Carto Vizigo, Bi-Directional Guiding Sheath, 8.5F (Large) C3 recalled

Biosense Webster is recalling Carto Vizigo, Bi-Directional Guiding Sheath, 8.5F (Large) C3. The recall was initiated on 26 Feb 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots

Quantity recalledN/A

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-1286-2021
FDA event ID: 87440
Recalling firm: Biosense Webster, Irwindale, CA
Classification: Class II
Status: Completed
Recall initiated: 26 Feb 2021
FDA classified: 22 Mar 2021
Reported: 31 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Feb 2021	Recall initiated by company
22 Mar 2021	Classified by FDA	+24 days
31 Mar 2021	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

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

Product as listed by the FDA

Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

Which lots are affected?

All Lots

Where was it sold?

Worldwide 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 87440

Reported	Class	Recall	Company	Reason	Where
31 Mar 2021	CLASS II	Carto Vizigo, Bi-Directional Guiding Sheath, 8.5F (Small) C3 recalled	Biosense Webster	Other	CA
31 Mar 2021	CLASS II	Carto Vizigo, Bi-Directional Guiding Sheath, 8.5F (medium) C3 recalled	Biosense Webster	Other	CA

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, 8.5F(Medium) recalled	Biosense Webster	Labeling Errors	Nationwide
12 Apr 2023Device	CLASS II	Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small) recalled	Biosense Webster	Labeling Errors	Nationwide
14 Sep 2022Device	CLASS II	Carto Vizigo 8.5F Bi-Directional Guiding Sheath recalled	Biosense Webster	Sterility	Nationwide

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