Cool-tip CTRF 100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884524002774), received between Nov 16, 2018 and Dec 29, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

1 other recall cover devices cleared under the same FDA submission (K973297); 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2020Device Alarm System; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS SCHEDULED TO RECEIVE A HEPATECTOMY AND ABLATION, HOWEVER, ABLATION WAS DISCONTINUED DUE TO THE RESISTANCE VALUE WAS HIGH AND HHH WAS DISPLAYED. THERE WERE NO PROBLEMS WITH THE CONNECTION WITH THE RETURN ELECTRODE PLATE, THE NEEDLE WAS REPLACED, BUT IT DID NOT CHANGE. IT HAS NOT BEEN DETERMINED WHETHER IT WILL BE PERCUTANEOUSLY DONE AT A LATER DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11085553 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, AT THE MIDDLE OF ABLATION PROCEDURE, THE UNIT SUDDENLY TURNED OFF. EVEN THOUGH THE UNIT WAS RESTARTED, THE INDICATOR TURNED ON BUT THE DEVICE DID NOT START UP. THE PROCEDURE WAS NOT COMPLETED. REOPERATION WAS REQUIRED DUE TO THE ISSUE. THE PATIENT WAS UNDER A LOCAL ANESTHESIA WHEN THE UNIT STOPPED WORKING. THE PROCEDURE WAS RESCHEDULE THE FOLLOWING DAY AND THEY PERFORMED USING AN ALTERNATIVE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 10130187 ↗
• InjuryNov 16, 2018Device Displays Incorrect Message; Electromagnetic Compatibility Problem; Device Displays Incorrect Message; Electromagnetic Compatibility Problem

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE BEFORE APPLYING LOCAL ANESTHESIA, AFTER TURNING ON THE POWER OF THE GENERATOR AND AFTER THE SELF TEST, AN ERROR (IMPEDANCE TEST FAILED) WAS GENERATED. ALTHOUGH THE POWER WAS TURNED OFF AND TURNED ON AGAIN, THE PROBLEM WAS NOT SOLVED AND THE PROCEDURE WAS STOPPED.

  Patient problems: No Code Available

  MAUDE report 8081317 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K973297. One submission often covers many models, so check the product and lot details in each record.

• Z-2301-2012 · Aug 1, 2012 · Terminated
  DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surg