# FDA recall Z-1234-2025

> **Scientia Vascular, Inc.** · Class II · device recall initiated 2025-01-02.

## Product

Socrates 38 Aspiration Catheter  127 cm length REF SC038-127-001    The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke

## Reason for recall

Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.

## Distribution

U..S. Nationwide distribution in the states of AL, AZ, FL, GA, HI, IL, IN, KS, MN, NC, NJ, NY, PA, SD, TX, VA, WI and WV.

## Key facts

- **Recall number:** Z-1234-2025
- **Recalling firm:** Scientia Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-02
- **Report date:** 2025-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Valley City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2025

## Citation

> AI Analytics. FDA recall Z-1234-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1234-2025. Source: US FDA. Licensed CC0.

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