Recall Z-1290-2024— Biosense Webster, Inc.

Name: FDA recall Z-1290-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-16

Class II · Ongoing

Class II FDA medical device recall by Biosense Webster, Inc., initiated 2024-02-16. It names one FDA 510(k) clearance: K170997. 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.. Reason: Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process..

Recalling firm: Biosense Webster, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-02-16
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K170997 — CARTO VIZIGO 8.5F Bi-Directional Guiding SheathBiosense Webster, Inc.·cleared 2017-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.