NA CLASSIC (REF S-1010-18)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067028617), received between Dec 26, 2024 and Dec 26, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K090955); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2024Thermal Decomposition of Device; Material Separation; Thermal Decomposition of Device; Material Separation

  IT WAS REPORTED THAT THE CANNULA COATING HAD MELTED. AS SUCH, THE RF PROCEDURE WAS NOT COMPLETED. THE PROCEDURE WAS CONVERTED TO ANESTHETIC BLOCK TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020809 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090955. One submission often covers many models, so check the product and lot details in each record.

• Z-0720-2020 · Nov 11, 2019 · Terminated
  CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved,