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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96158

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 02, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Scientia Vascular, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1234-2025
Recall number
Z-1234-2025
Initiated
January 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Scientia Vascular, Inc.
Quantity
120 devices

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451

Distribution pattern

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.