Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suc
Summary
The FDA issued a Class II for Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates by Scientia Vascular, Inc.. 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 i.
Details
Source
Device Recall
External ID
Z-1234-2025
Action Date
2025-03-05
Status
Ongoing
Category
device
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
Lot/Code Info: Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451
Quantity Affected: 120 devices
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-02
Company
West Valley City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Scientia Vascular, Inc. has 9 FDA actions in our database, including 3 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Scientia Vascular, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Scientia Vascular, Inc. have FDA actions?
Scientia Vascular, Inc. has 9 FDA actions in our database, including 3 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1234-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29