Scientia Vascular, Inc. recalls Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suc

Recalled March 5, 2025 · FDA recall Z-1234-2025 · Scientia Vascular

Hazard

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. · FDA Class II

Units

120 devices

Sold at

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.

Description

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

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

Manufacturer(s)

Scientia Vascular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →