Socrates recallZ-1234-2025 · Scientia Vascular, Inc. · initiated Jan 2, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Scientia Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
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 instructed to: Segregate Recalled Product. Immediately remove all impacted (see list above) Socrates 38 Catheter(s) from their inventory (regardless of its location) and segregate this product in a secure location for return to Scientia Vascular, Inc. In situations where a device has already been used in a patient procedure, closely monitor patients for signs and symptoms of post-surgical infection. Customer Service will be available to provide additional information and provide replacement orders at [email protected] or (888)385-9016; Monday through Friday, 8:00 AM to 4:30 PM, Mountain Time.
Recall details
- Recall number
- Z-1234-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 2, 2025
- Posted by the FDA
- Feb 26, 2025
- Recalling firm
- Scientia Vascular, Inc.
- Quantity
- 120 devices
- Product code
- NRY
- FDA submissions
- K223913
- 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.
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
Code information (models, lots, serial numbers)
Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Socrates SC038-127-001Scientia Vascular LLC · Catheter, Thrombus Retriever1 recall2 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K223913 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Socrates SC038-156-001Scientia Vascular LLC · Catheter, Thrombus Retriever3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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