Recall Z-1234-2025— Scientia Vascular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Scientia Vascular, Inc., initiated 2025-01-02. It names one FDA 510(k) clearance: K223913. 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: 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..
- Recalling firm
- Scientia Vascular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-02
- Firm location
- West Valley City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.