Recall Z-1234-2025 ยท NRY Catheter, Thrombus Retriever
Scientia Vascular, Inc.
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
| Date | Feb 26, 2025 (initiated Jan 2, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 01/02/2025, the firm initially notified customer via email an "URGENT: MEDICAL DEVICE RECALL" Letter informing them that through internal evaluation of finished goods of the Socrates 38 Aspiration Catheter, one lot of pouches containing the 127 cm Socrates 38 Aspiration Catheter was identified with pouches that had a gap in the sterile barrier seal. This was a result of the pouch not being centered with the sealing bar during the sealing process. On 01/10/2025, The firm sent an updated letter informing customers of additional product lots were added to the Recall. Customers are instructe |
| Quantity | 120 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223913 | Socrates Aspiration System Scientia Vascular, Inc., Sep 20, 2023 |