Z-1320-2023Class II

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797...

Name: Z-1320-2023 Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797...
Creator: Biosense Webster, Inc.
Published: 2023-02-21
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2023-02-21 / Open, Classified / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile on 2023-02-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1320-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-21
Posted: 2023-04-01
Recalling firm: Biosense Webster Inc
Product: Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Product code: DYB Introducer, Catheter
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
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On March 2, 2023, Biosense Webster, Inc. issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" notification to affected US customers via FedEx. The notification was issued to foreign consignees on February 29, 2023. In addition to informing consignees about the recall Biosense Webster asked customer to take the following actions: 1. Carefully review the information contained in this Medical Device Correction/Removal. 2. Ensure that anyone in your facility who needs to be aware of this notification reads the attached letter carefully. 3. Evaluate if you have inventory of CARTO VIZIGO" Bi-Directional Guiding Sheath (Catalog Numbers: D-1385-01-S and D-1385-02-S) Lot Numbers 00002137 and 50000224 and segregate the product. For assistance in identifying impacted product, please reference ATTACHMENT 1: PRODUCT IDENTIFICATION TOOL. 4. Complete all fields of the attached Business Response Form. Please make sure to include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. 5. If you have inventory affected by this action: 5.1. Return inventory to Sedgwick using the enclosed return label. 5.2. Complete and sign the Business Response Form 5.3. Scan the signed completed form and email it to: [email protected] or Fax it to 888-877-7241. Subject: Attention: BWI Field Action Event #7774 6. If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this to the relevant personnel. 7. Maintain a copy of this communication where the product identified in this letter is located until all products have been destroyed.
Quantity in commerce: 316 units
Distribution: 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.
Product codes and lots: Lot # 50000224; UDI (GTIN) : 10846835016277

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1320-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1319-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-03-31
Z-1320-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-03-31

Product code DYB

K170997Class IICARTO VIZIGO 8.5F Bi-Directional Guiding SheathBiosense Webster, Inc. / cleared 2017-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)