PlatoRecalls & reported problems across all models

We found 3 models of Plato by Scientia Vascular LLC in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2026 and Feb 20, 2026 — classified as 3 malfunctions.

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

2 FDA recall records name at least one of these models by its device identifier, 2 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

Plato 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 16, 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-1235-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 1, 2023Class IIOpen, Classified

   Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to placement, may have loose particles within catheter lumens that may be introduced to patients, which could cause embolic event, small vessel occlusion, and subacute to chronic inflammatory response.

   Z-1249-2023 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

Most reported Plato problems

Plato models

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

• Plato 17-160-090

  Catheter, Percutaneous
  2 recalls0 reports
• Plato 17-160-000

  Catheter, Percutaneous
  1 recall3 reports
• Plato 17-160-045

  Catheter, Percutaneous
  1 recall0 reports

Recent Plato adverse event reports

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

• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE THE PHYSICIAN ACCESSED THE MMA WITH A PLATO 17 (PL17-160-000) THROUGH A PENUMBRA 5F BER CATHETER. THE PHYSICIAN DID A MICRO INJECTION AND WHEN THEY LOOKED DOWN THE HUB OF THE PLATO 17 HAD BROKEN OFF. THE BROKEN DEVICE WAS REMOVED AND ANOTHER PLATO 17 WAS USED TO FINISH THE CASE. THE PATIENT WAS NOT HARMED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24407816 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT AFTER A SPINAL EMBOIZATION PROCEDURE USING A PLATO 17 CATHETER TO INJECT PARTICLES THE CATHETER SNAPPED IN HALF. THE PHYSICIAN SAID ONE SECOND IT WAS TOGETHER AND THE NEXT IT WAS IN TWO PIECES. THEY ALSO NOTED THEY DID NOT PUT ANY EXTRA PRESSURE ON THE CATHETER THAN NORMAL. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319463 ↗
• MalfunctionJan 5, 2026Break

  DURING A NEUROVASCULAR PROCEDURE, THE DOCTOR WAS USING A PL17-160-000 CATHETER. THE DOCTOR WAS ABLE TO ACCESS THE MMA WITH THE CATHETER AND WHILE IN THE PROCESS OF DOING AN ANGIOGRAM USING A 3CC MEDALLION SYRING AND THE CATHETER BROKE AT THE HUB. THE CATHETER WAS REPLACED WITH ANOTHER PRODUCT AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT OR ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961152 ↗

Other Scientia Vascular LLC products

• Aristotle12 models · 64 reports
• Socrates2 models · 5 reports · 1 recall