Scientia Vascular, Inc.: Device Recall

Recall #Z-1234-2025 · 01/02/2025

Class II: Risk

Recall Details

Recall Number: Z-1234-2025
Classification: Class II
Product Type: Device
Recalling Firm: Scientia Vascular, Inc.
Status: Ongoing
Date Initiated: 01/02/2025
Location: West Valley City, UT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 120 devices

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.

Product Description

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

Distribution Pattern

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.

Other Recalls by Scientia Vascular, Inc.

Class II: Risk 01/16/2025

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.

View all recalls by Scientia Vascular, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.