CLASS II ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report

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

Biosense Webster is recalling Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), distributed nationwide in the US. The recall was initiated on 21 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 00002137; UDI (GTIN) : 10846835016253

Quantity recalled277

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-1319-2023
FDA event ID: 91797
Recalling firm: Biosense Webster, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Feb 2023
FDA classified: 31 Mar 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

21 Feb 2023	Recall initiated by company
31 Mar 2023	Classified by FDA	+38 days
12 Apr 2023	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

Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

Product as listed by the FDA

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

Where it was distributed

Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI. The country of Japan.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Indiana Kansas Kentucky Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Questions about this recall

Why was it recalled?

Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

Which lots are affected?

Lot # 00002137; UDI (GTIN) : 10846835016253

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 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

1 other product · FDA event 91797

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023	CLASS II	Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium) recalled	Biosense Webster	Labeling Errors	Nationwide

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
14 Sep 2022Device	CLASS II	Carto Vizigo 8.5F Bi-Directional Guiding Sheath recalled	Biosense Webster	Sterility	Nationwide
31 Mar 2021Device	CLASS II	Carto Vizigo, Bi-Directional Guiding Sheath, 8.5F (medium) C3 recalled	Biosense Webster	Other	CA

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