Biosense Webster, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1319-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 21, 2023

Date Posted: April 12, 2023

Recall Number: Z-1319-2023

Event ID: 91797

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

Status: Ongoing

Product Quantity: 277

Code Information:

Lot # 00002137; UDI (GTIN) : 10846835016253

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated