# FDA recall Z-1677-2022

> **Biosense Webster, Inc.** · Class II · device recall initiated 2022-06-29.

## Product

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501.  Used to introduce various cardiovascular catheters into the heart.

## Reason for recall

Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside.  Devices with a compromised sterile barrier could be a source for infection.

## Distribution

US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.

## Key facts

- **Recall number:** Z-1677-2022
- **Recalling firm:** Biosense Webster, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-29
- **Report date:** 2022-09-14

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1677-2022

## Citation

> AI Analytics. FDA recall Z-1677-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1677-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*