# FDA recall Z-1290-2024

> **Biosense Webster, Inc.** · Class II · device recall initiated 2024-02-16.

## 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 for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-1290-2024
- **Recalling firm:** Biosense Webster, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-16
- **Report date:** 2024-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1290-2024

## Citation

> AI Analytics. FDA recall Z-1290-2024. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1290-2024. Source: US FDA. Licensed CC0.

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