Socrates SC038-156-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818075010776), received between Sep 18, 2025 and Nov 26, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K223913); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Break; Break

  DURING A NEUROVASCULAR PROCEDURE THE PHYSICIAN WAS USING A SOCRATES 038 CATHETER IN CONJUNCTION WITH A RED 72 CATHETER AS WELL AS AN ARISTOTLE COLOSSUS WIRE. THE SOCRATES CATHETER AND COLOSSUS WIRE TRACKED NICELY AND GOT WHERE IT WAS NEEDED, HOWEVER, WHEN THE PHYSICIAN TRIED TO ADVANCE THE RED 72 CATHETER IT WOULD NOT GO. THE PHYSICIAN THEN APPLIED SUCTION USING THE SOCRATES BUT THE CLOT WAS TOO LARGE. THE PHYSICIAN TRIED TO REMOVE THE SOCRATES CATHETER BUT IT GOT STUCK AND BROKE AT THE DISTAL 1/3 OF THE CATHETER. THE PHYSICIAN WAS ABLE TO GET THE CATHETER PIECE OUT BY APPLYING SUCTION USING THE RED 72 CATHETER. THE PHYSICIAN ALSO NOTED A LOT OF TORTUOSITY IN THE VESSEL AND A STENOSIS IN THE COMMON CAROTID ARTERY. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE MALFUNCTION AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH OTHER PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663168 ↗
• InjuryNov 26, 2025Break; Break

  DURING A NEUROVASCULAR PROCEDURE THE PHYSICIAN WAS USING A SOCRATES 038 CATHETER IN CONJUNCTION WITH A RED 72 CATHETER AS WELL AS AN ARISTOTLE COLOSSUS WIRE. THE SOCRATES CATHETER AND COLOSSUS WIRE TRACKED NICELY AND GOT WHERE IT WAS NEEDED, HOWEVER, WHEN THE PHYSICIAN TRIED TO ADVANCE THE RED 72 CATHETER IT WOULD NOT GO. THE PHYSICIAN THEN APPLIED SUCTION USING THE SOCRATES BUT THE CLOT WAS TOO LARGE. THE PHYSICIAN TRIED TO REMOVE THE SOCRATES CATHETER BUT IT GOT STUCK AND BROKE AT THE DISTAL 1/3 OF THE CATHETER. THE PHYSICIAN WAS ABLE TO GET THE CATHETER PIECE OUT BY APPLYING SUCTION USING THE RED 72 CATHETER. THE PHYSICIAN ALSO NOTED A LOT OF TORTUOSITIES IN THE VESSEL AND A STENOSIS IN THE COMMON CAROTID ARTERY. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE MALFUNCTION AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH OTHER PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663103 ↗
• MalfunctionSep 18, 2025Break; Break

  DURING A NEUROVASULAR STROKE CASE THE PHYSICIAN WAS USING A RED 62 REPERFUSION CATHETER IN CONJUNCTION WITH A SOCRATES 38 ASPIRATION CATHETER AND A ARISTOTLE COLOSSUS GUIDEWIRE. DURING THE CASE THE PHYSICIAN WAS ABLE TO ADVANCE THE SOCRATES 38 AND COLOSSUS GUIDEWIRE BEYOND THE OPHTHALMIC, BUT UNABLE TO ADVANCE THE LARGE BORE CATHETER. THE PHYSICIAN SUBSEQUENTLY ATTEMPED TO REMOVE THE CATHETER. DURING THE REMOVAL OF THE SOCRATES 38 CATHETER FROM THE SYSTEM THE PHYSICIAN FELT RESISTANCE UPON WHICH THE SOCRATES CATHETER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086471 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223913. One submission often covers many models, so check the product and lot details in each record.

• Z-1234-2025 · Jan 2, 2025 · Open, Classified
  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 pati