Coblation ASHA3730-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470003017), received between Mar 31, 2026 and Apr 1, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING PROCEDURES, AT LEAST TEN (10) AMBIENT COVAC 70 WANDS SHEATHS WERE BURNING. IT IS UNKNOWN THE EXACT NUMBER OF PATIENTS WHO EXPERIENCED THIS ISSUE, HOW THESE SURGERIES WERE COMPLETED, OR THE OUTCOMES FOR THE PATIENTS INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755204 ↗
• MalfunctionMar 31, 2026Material Fragmentation; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING A PROCEDURE, FIVE (5) AMBIENT COVAC 70 WAND SHEATHS WERE BURNING. FRAGMENTATION OF PIECES OCCURRED; ALL PIECES WERE RETRIEVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742313 ↗