# FDA recall Z-1285-2021

> **Biosense Webster, Inc.** · Class II · device recall initiated 2021-02-26.

## Product

Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.

## Reason for recall

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath.  This could result in minor bleeding and/or  embolism

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1285-2021
- **Recalling firm:** Biosense Webster, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-02-26
- **Report date:** 2021-03-31

- **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-1285-2021

## Citation

> AI Analytics. FDA recall Z-1285-2021. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1285-2021. Source: US FDA. Licensed CC0.

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