Cool-tip ACTC1525Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884524001203), received between Mar 9, 2017 and Jan 2, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2019Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, BEFORE THE START OF THE OPERATION, THE RADIO FREQUENCY MACHINE PASSED THE SELF-TEST. AFTER INSERTING INTO THE RF NEEDLE. WHEN THE ABLATION WAS READY, THE TEMPERATURE WINDOW SHOWED A RAPID INCREASE IN TEMPERATURE. IT AUTOMATICALLY CLOSED AFTER REACHING HH. AFTER THE REPLACEMENT OF THE RF NEEDLE, THE OPERATION PROCEEDED SMOOTHLY. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8209700 ↗
• MalfunctionSep 18, 2018Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THERE WAS AN ALARM PROBLEM AND BEFORE THE START OF THE OPERATION FOR A LIVER TUMOR, THE RADIO FREQUENCY MACHINE PASSED THE SELF-TEST AND THE RF NEEDLE WAS INSERTED. WHEN THE ABLATION WAS READY, THE TEMPERATURE WINDOW SHOWED A RAPID INCREASE IN TEMPERATURE. BEING THAT HIGH, THE DEVICE AUTOMATICALLY SHUT DOWN AFTER HH, THE OPERATION WAS SUCCESSFUL AFTER REPLACING THE RF NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 7884907 ↗
• MalfunctionSep 17, 2018Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD AN ALARM PROBLEM ALSO, BEFORE THE START OF THE OPERATION FOR A LIVER TUMOR, THE RADIO FREQUENCY MACHINE PASSED THE SELF-TEST AND THE RF NEEDLE WAS INSERTED. WHEN THE ABLATION WAS READY, THE TEMPERATURE WINDOW SHOWED A RAPID INCREASE IN TEMPERATURE. BEING THAT HIGH, THE DEVICE AUTOMATICALLY SHUTS DOWN AFTER HH, THE OPERATION WAS SUCCESSFUL AFTER REPLACING THE RF NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7882772 ↗
• MalfunctionMar 9, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE ELECTRODE DID NOT WORK, THERE WAS NO SHOW MEASUREMENT OF TEMPERATURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6391053 ↗
• MalfunctionMar 9, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE ELECTRODE DID NOT WORK, THERE WAS NO SHOW MEASUREMENT OF TEMPERATURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6391025 ↗