Cool-tip ACTC2025Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884524001197), received between May 9, 2017 and Sep 20, 2021 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionSep 20, 2021Leak/Splash; No Flow; Leak/Splash; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD A CIRCULATION FAILURE AND WATER LEAKED. THEY REPLACED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496778 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED YEAR 2019, A (B)(6)-YEAR-OLD FEMALE WAS ADMITTED BECAUSE REGULAR FOLLOW-UP IMAGES SHOWED AN ENLARGING SUBCAPSULAR HEPATIC HEMANGIOMA WITHIN THE PAST 4 YEARS. THE TUMOR MASS WAS NOT PALPABLE BY PHYSICAL EXAMINATION. CONTRAST-ENHANCED CT SHOWED A TYPICAL HEPATIC HEMANGIOMA IN THE LEFT MEDIAL LOBE (10.7 CM×8.2 CM). A CONSENSUS THAT LAPAROSCOPIC RF ABLATION WAS THE OPTIMAL THERAPY FOR THE TUMOR WAS MADE BY A MULTIDISCIPLINARY PANEL OF EXPERTS IN HEPATOBILIARY TUMOR TREATMENT. TWO HEPATOBILIARY SURGEONS PERFORMED THE LAPAROSCOPIC PROCEDURES. BRIEFLY, THE PATIENT WAS PLACED SUPINE ON THE SURGICAL TABLE. UNDER ENDOTRACHEAL INHALATION ANESTHESIA, A 10 MM INCISION WAS MADE AT THE UMBILICUS. FOLLOWING A PNEUMOPERITONEUM AT 14 MMHG, TWO ADDITIONAL TROCARS WERE PLACED UNDER THE DIRECT LAPAROSCOPIC VISION. THE LAPAROSCOPIC EXPLORATION FOUND AN APPROXIMATELY 10.7 CM TUMOR MASS BULGING FROM THE LEFT MEDIAL LOBE. ANOTHER 10 MM SUBXIPHOID PORT WAS CREATED AT THE MIDLINE OF ABDOMEN. UNDER US GUIDANCE, THE RF PROBE WAS INTRODUCED INTO THE PERITONEAL CAVITY THROUGH THE SUBCOSTAL TROCARS UNDER THE DIRECT LAPAROSCOPIC VISION AND DEPLOYED INTO THE TUMOR.

  Patient problems: Dyspnea; Fever; Low Blood Pressure/ Hypotension; No Code Available

  MAUDE report 8911900 ↗
• MalfunctionOct 19, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE TEMPERATURE INCREASED UNTIL THE UNIT SHUT DOWN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963898 ↗
• MalfunctionMay 9, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE OF RADIOFREQUENCY ABLATION THE TEMPERATURE DISPLAYED ON THE SCREEN REMAINED AT AROUND 95 DEGREE CENTIGRADE. THE PHYSICIAN SHUT DOWN THE DEVICE AND CHECKED THE WATER CIRCULATION, NEGATIVE PLATE AND CONNECTING CABLE. NOTHING WRONG WAS FOUND. THEN THE PHYSICIAN REPLACED THE NEEDLE ELECTRODE AND FINISHED THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6555005 ↗