Scientia Vascular, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1234-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 2, 2025

Date Posted: March 5, 2025

Recall Number: Z-1234-2025

Event ID: 96158

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.

Status: Ongoing

Product Quantity: 120 devices

Code Information:

Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451

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.

Voluntary or Mandated:

Voluntary: Firm initiated