device · product 1 of 1
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.
- Recall number
- Z-1290-2024
- Initiated
- February 16, 2024
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 853 units
App-derived interpretation
Unknown
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Code information
Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282
Distribution pattern
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.