Cool-tip ACT1507Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524001166), received between Jun 17, 2019 and Jan 16, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Electrical Shorting” (1 report).

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.

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.

• InjuryJan 16, 2026No Flow; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO THE WATER TEMPERATURE WAS NOT RISING.

  Patient problems: Insufficient Information

  MAUDE report 24094322 ↗
• MalfunctionJun 17, 2019Failure to Fire; Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE ABLATION PROCESS, THE RF NEEDLE DID NOT EMIT POWER, AND THE ULTRASOUND EXAMINATION HAD NO EFFECT. THEY PERFORMED POSTOPERATIVE EXPERIMENTS ON PIG LIVER WHICH SHOWED THAT THE NEEDLE HANDLE HAD ELECTRIC LEAKAGE WHICH HAD CAUSED SLIGHT REDNESS WITH THE COLLEAGUE'S HAND WITH SLIGHT REDNESS. IT WAS TREATED WITH COLD COMPRESS. THEY REPLACED THE RF NEEDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 8706179 ↗