Reported Mar 20, 2024 · Ongoing
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to…
Biosense Webster, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biosense Webster, Inc. · 31 Technology Dr Ste 200 · Irvine, CA · 92618-2302
Is this the product you have?
- 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.
- Lot codes and dates
- Product No
- D-1385-02 UDI-DI code10846835016277
- Lot Numbers60000282 60000282
- Amount recalled
- 853 units
Where it was sold
Why it was recalled
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
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