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

FDA device recall Z-1234-2025 · posted 2025-02-26 · Open, Classified

Recall details

Recalling firm

Scientia Vascular, Inc.

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.

Action taken

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 customercare@scientiavascular.com or (888)385-9016; Monday through Friday, 8:00 AM to 4:30 PM, Mountain Time.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NRY

Quantity affected

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.

Date initiated

2025-01-02

Date posted

2025-02-26

Location

West Valley City, UT

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