Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The… — Class II medical device recall Z-1234-2025
Ongoing recall by Scientia Vascular, Inc., reported 2025-03-05, distributed nationwide. Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result
| Recall number | Z-1234-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Scientia Vascular, Inc., West Valley City, UT, United States |
| Recall initiated | 2025-01-02 |
| Classified | 2025-02-26 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 120 devices |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00818075011025 |
| Lot numbers | 030317, 030345, 030376, 030427, 030451, 030471 |
| Model numbers | C038-127-001, SC038-127-001 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1234-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.