Socrates SC038-127-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818075011025), received between Oct 3, 2024 and Dec 27, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 2, 2025Class IIOpen, Classified

   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.

   Z-1234-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2025Break; Break

  DURING AN INTRACRANIAL COILING OF A PERICALLOSAL HEMORRHAGE ANEURYSM A SOCRATES 038 CATHETER FRACTURED AND BECAME DISPLACED/SEPARATED WHILE INSIDE OF A ZEBRA GUIDE CATHETER. THE PHYSICIAN NOTED THE ZEBRA CATHETER WAS KINKED BUT ALSO NOTED THE PROCEDURE WAS COMPLETED WITH A BENCHMARK CATHETER THROUGH THE SAME ZEBRA CATHETER WITHOUT INCIDENT AND THERE WAS NO INJURY TO THE PATIENT. THE PHYSICIAN NOTED TORTUOUS ANATOMY AND AN ACUTE TURN GOING FROM THE A1 TO THE A2 BRANCH. THE DISPLACED PIECE OF THE SOCRATES 038 CATHETER WAS REMOVED FROM THE ZEBRA CATHETER USING ASPIRATION BEFORE CONTINUING THE PROCEDURE USING THE BENCHMARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903168 ↗
• InjuryOct 3, 2024Break; Break

  ON 03 SEP 2024, SCIENTIA VASCULAR WAS NOTIFIED THAT A SOCRATES 38 (SC038-127-001, LN: 029278) ASPIRATION CATHETER DISTAL TIP DETACHED DURING A STROKE PROCEDURE. THE BREAK OCCURRED WHEN THE DOCTOR WAS PULLING THE SOCRATES 038 ASPIRATION CATHETER INTO THE CEREBASE GUIDE CATHETER. THE BROKEN PIECE OF THE SOCRATES 038 REMAINED IN THE PATIENT SUPPORTED BY A STENT. THE EVENT WAS INITIALLY DESCRIBED AS FOLLOWS: "DURING A STROKE THE SOC 127 / HEADWAY DUO 167 / TIGER 13 WAS ADVANCED. TIGER 13 WAS DEPLOYED THEN CONSTRAINED 50% AND PULLED BACK. IT WAS THEN CONSTRAINED ANOTHER 25% TO FIT INTO THE GUIDE. WHILE PULLING EVERYTHING BACK INTO THE GUIDE THE TIP OF THE SOC127 DETACHED AND WENT DISTAL. THE DOCTOR TRIED TO RETRIEVE IT BUT COULD NOT. HE ENDED UP STETTING OVER IT." THE COMPLAINT UNIT (SOCRATES 038) WAS RETURNED TO SCIENTIA VASCULAR ON 10-SEP-2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 20362704 ↗