Z-1234-2025Class II

Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a...

Name: Z-1234-2025 Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a...
Creator: Scientia Vascular, Inc.
Published: 2025-01-02
License: https://open.fda.gov/license/

Scientia Vascular / initiated 2025-01-02 / Open, Classified / root cause: packaging

FDA source

Scientia Vascular, Inc. began a recall of 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... on 2025-01-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1234-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-02
Posted: 2025-02-26
Recalling firm: Scientia Vascular
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
Product code: NRY Catheter, Thrombus Retriever
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.
Root cause tag: packaging
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1234-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1234-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-26

Product code NRY

K223913Class IISocrates Aspiration SystemScientia Vascular, Inc. / cleared 2023-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)