Biosense Webster, Inc. recalls CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed

Recalled March 20, 2024 · FDA recall Z-1290-2024 · Biosense Webster

Hazard

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process. · FDA Class II

Units

853 units

Sold at

U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA, SC, AZ, MI KY, NJ, WI, IN, LA, TX, MA, OH, AR, MT, MO, VA, NC, TN, CA, MN, WV, CT, CO, IA, MD, ID, NM, NH, UT, GA, WA, NV, OK, KS, AK, NE, HI.

Description

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

Product

CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and counterclockwise = 180¿. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems.

Manufacturer(s)

Biosense Webster, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →