FDA Medical devices recall ·
Socrates 38 Aspiration Catheter 127 cm length recall
- Recall number
- Z-1234-2025
- Date
- (initiated January 2, 2025)
- Company / brand
- Scientia Vascular, Inc.
2460 S 3270 W, West Valley City, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 120 devices
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451
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.
States: Alabama Arizona Florida Georgia Hawaii Illinois Indiana Kansas Minnesota North Carolina New Jersey New York Pennsylvania South Dakota Texas Virginia Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1234-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.