Plato 17-160-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818075010455), received between Jan 5, 2026 and Feb 20, 2026 — classified as 3 malfunctions.

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

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

1 other recall cover devices cleared under the same FDA submission (K210601, K223560); 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 16, 2026.

Recalls naming this device

1. Feb 1, 2023Open, 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 · Recall details · FDA record ↗

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.

• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210601, K223560. One submission often covers many models, so check the product and lot details in each record.

• Z-1235-2025 · Jan 16, 2025 · Open, Classified
  Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vascu