CLASS II ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report
Socrates 38 Aspiration Catheter length recalled by Scientia Vascular
Scientia Vascular is recalling Socrates 38 Aspiration Catheter length, distributed nationwide in the US. The recall was initiated on 2 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1234-2025
- FDA event ID
- 96158
- Recalling firm
- Scientia Vascular, West Valley City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jan 2025
- FDA classified
- 26 Feb 2025
- Reported
- 5 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 2 Jan 2025 | Recall initiated by company | |
| 26 Feb 2025 | Classified by FDA | +55 days |
| 5 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArizonaFloridaGeorgiaHawaiiIllinoisIndianaKansasMinnesotaNorth CarolinaNew JerseyNew YorkPennsylvaniaSouth DakotaTexasVirginiaWisconsinWest Virginia
Questions about this recall
Why was it 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.
Which lots are affected?
Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Scientia Vascular
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