SMK™ SMK-C1010-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067028730), received between Jun 24, 2022 and Apr 28, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Product Quality Problem” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Product Quality Problem

  IT WAS REPORTED THAT DURING AN RFA PROCEDURE THE PHYSICIAN NOTICED THAT ONCE THE NEEDLE WAS REMOVED FROM THE PATIENT THE WHITE COATING WAS MISSING. THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE EFFECTS AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015910 ↗
• InjuryApr 28, 2026Product Quality Problem

  IT WAS REPORTED THAT DURING AN RFA PROCEDURE THE PHYSICIAN NOTICED THAT ONCE THE NEEDLE WAS REMOVED FROM THE PATIENT THE WHITE COATING WAS MISSING. THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE EFFECTS AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015877 ↗
• InjuryApr 28, 2026Product Quality Problem

  IT WAS REPORTED THAT DURING AN RFA PROCEDURE THE PHYSICIAN NOTICED THAT ONCE THE NEEDLE WAS REMOVED FROM THE PATIENT THE WHITE COATING WAS MISSING. THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE EFFECTS AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015814 ↗
• InjuryApr 28, 2026Product Quality Problem

  IT WAS REPORTED THAT DURING AN RFA PROCEDURE THE PHYSICIAN NOTICED THAT ONCE THE NEEDLE WAS REMOVED FROM THE PATIENT THE WHITE COATING WAS MISSING. THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE EFFECTS AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015805 ↗
• InjuryJun 24, 2022Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE WHEN THE PHYSICIAN REMOVED THE NEEDLE FROM THE PATIENT, FRAGMENTS OF THE CANNULA WERE MISSING AND REMAIN IN THE PATIENT. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE OR LOCAL REACTIONS DUE TO THE FRAGMENTS BEING LEFT IN THEIR BODY AND NO INTERVENTIONS ARE PLANNED TO REMOVE THE FRAGMENTS AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806512 ↗
• InjuryJun 24, 2022Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE WHEN THE PHYSICIAN REMOVED THE NEEDLE FROM THE PATIENT, FRAGMENTS OF THE CANNULA WERE MISSING AND REMAIN IN THE PATIENT. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE OR LOCAL REACTIONS DUE TO THE FRAGMENTS BEING LEFT IN THEIR BODY AND NO INTERVENTIONS ARE PLANNED TO REMOVE THE FRAGMENTS AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806503 ↗