# FDA recall Z-2426-2018

> **Stryker Sustainability Solutions** · Class II · device recall initiated 2018-03-29.

## Product

Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304.    Product Usage:  The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

## Reason for recall

Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of  non-thrombogenic .

## Distribution

Worldwide Distribution - US Nationwide and Canada

## Key facts

- **Recall number:** Z-2426-2018
- **Recalling firm:** Stryker Sustainability Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-29
- **Report date:** 2018-07-18
- **Termination date:** 2020-07-28

- **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-2426-2018

## Citation

> AI Analytics. FDA recall Z-2426-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2426-2018. Source: US FDA. Licensed CC0.

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