FDA recall Z-1234-2025

Scientia Vascular, Inc. · Class II · device

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

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

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