SocratesRecalls & reported problems across all models

We found 2 models of Socrates by Scientia Vascular LLC in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2024 and Dec 27, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Socrates recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 2, 2025Open, 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 Socrates problems

Socrates models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Socrates SC038-127-001

  Catheter, Thrombus Retriever
  1 recall2 reports
• Socrates SC038-156-001

  Catheter, Thrombus Retriever
  3 reports

Recent Socrates adverse event reports

The 5 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗

Other Scientia Vascular LLC products

• Plato3 models · 3 reports · 2 recalls
• Aristotle12 models · 64 reports