# FDA recall Z-0021-2025

> **Stryker Neurovascular** · Class II · device recall initiated 2024-08-30.

## Product

The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization.  A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.

## Reason for recall

Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.

## Distribution

U.S. Nationwide distribution in the states of CA and VA.

## Key facts

- **Recall number:** Z-0021-2025
- **Recalling firm:** Stryker Neurovascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-30
- **Report date:** 2024-10-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0021-2025

## Citation

> AI Analytics. FDA recall Z-0021-2025. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-0021-2025. Source: US FDA. Licensed CC0.

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