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Recent Recall Details


CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Direct ...


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.
Components:
Product
No.
D-1385-02
UDI-DI
code:
10846835016277
Lot
Numbers:
60000282
60000282
Recall Date:    Feb 16, 2024
Mfg:
Biosense Webster, Inc.
Mfg Country:
United States
Recall ID:    94014
Product ID:    206118
Enforcement Date:    Mar 20, 2024
Last Published:    Mar 13, 2024

__________

RecallMe Number:    Z-1290-2024
RecallMe Status:    Notified
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