# FDA recall Z-0467-2019

> **Stryker Sustainability Solutions** · Class II · device recall initiated 2018-08-23.

## Product

Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.

## Reason for recall

Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.

## Distribution

US: KS    OUS: None

## Key facts

- **Recall number:** Z-0467-2019
- **Recalling firm:** Stryker Sustainability Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-23
- **Report date:** 2018-11-21
- **Termination date:** 2021-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0467-2019

## Citation

> AI Analytics. FDA recall Z-0467-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0467-2019. Source: US FDA. Licensed CC0.

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