Cool-tip CTRF 220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884524002781), received between Aug 21, 2017 and Jun 19, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF RETROSPECTIVE STUDY PERFORMED BETWEEN FEBRUARY 2013 AND MAY 2021, THE LONG-TERM OUTCOMES OF RFA USING COOL-TIP RFA FOR PERIBILIARY AND NON-PERIBILIARY HCC USING PROPENSITY SCORE MATCHING (PSM), 282 PATIENTS WERE INCLUDED IN THIS RETROSPECTIVE STUDY. COMPLICATIONS INCLUDED INTRAHEPATIC BILE DUCT DILATATION (18), BILOMA FORMATION (1), BILIARY FISTULA (1), LIVER DECOMPENSATION (55), THROMBUS IN PERITUMORAL VESSEL (10), PAIN REQUIRING TREATMENT (19), INFECTION (14), HYDROPNEUMOTHORAX REQUIRING DRAINAGE (3). BILOMA FORMATION AND BILIARY FISTULA WERE TREATED WITH PERCUTANEOUS BILIARY DRAINAGE.

  Patient problems: Biliary Leak; Fistula; Liver Damage/Dysfunction; Pain; Pneumothorax; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22293714 ↗
• MalfunctionOct 2, 2019Break; Overheating of Device; Smoking; Adverse Event Without Identified Device or Use Problem; Break; Overheating of Device; Smoking; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AFTER THE PHYSICIAN PLACE THE CLUSTER ELECTRODE IN THE PATIENT BODY AND ONCE THE MACHINE WAS SWITCHED ON, THE MACHINE STARTED TO HEAT UP SUDDENLY AND THERE WERE BURNING SMOKE SENSATION OCCURRED. THE PROCEDURE WAS STOPPED AND DID NOT PROCEED ABLATING USING RADIO FREQUENCY ABLATION. SURGEON SWITCHED TO EMPRINT ANTENNA TO COMPLETE THE PROCEDURE WITH NO POST-PROCEDURAL ADVERSE EVENT HAPPENED TO THE PATIENT. WHOLE SET OF MACHINES AND CLUSTER ELECTRODE WERE RETURN BACK TO THE OFFICE. SERVICE ENGINEER AT THE FACILITY FOUND OUT THE PROBLEM THAT CAUSED THE SMOKE FROM THE UNIT WAS A FAULTY SYSTEM MAIN CIRCUIT BOARD.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9145582 ↗
• MalfunctionApr 15, 2019Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A TEMPERATURE TEST FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8515246 ↗
• MalfunctionAug 21, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT PRIOR TO USE, THE TEMPERATURE TEST FAILED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6807528 ↗

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