Cool-tip ACT2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10884524001227), received between Apr 15, 2016 and Dec 22, 2025 — classified as 8 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Device Alarm System; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Device Alarm System; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO TEMPERATURE ISSUE, SPECIFICALLY ABNORMAL WATER TEMPERATURE THAT EXCEEDED 99°C, WHICH TRIGGERED AN AUTOMATIC SHUTDOWN.

  Patient problems: Insufficient Information

  MAUDE report 23861778 ↗
• InjuryNov 18, 2025No Flow; Appropriate Device Problem Term/Code Not Available; No Flow; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO FAILURE TO CIRCULATE.

  Patient problems: Insufficient Information

  MAUDE report 23584234 ↗
• MalfunctionNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS VENTRICULAR SEPTAL MYOCARDIAL ABLATION, A PATIENT SUSTAINED TWO FIRST-DEGREE SKIN BURNS, EACH APPROXIMATELY 13 BY 7 CM ON THE LOWER RIGHT ABDOMEN. THE BURNS WERE ATTRIBUTED TO HEAT CONDUCTION FROM THE PRODUCT. FOLLOWING THE PROCEDURE, THE PATIENT RECEIVED WOUND DRESSING TREATMENT AND CONSULTATIONS WERE CONDUCTED WITH THE DERMATOLOGY DEPARTMENT, PLASTIC AND COSMETIC SURGERY DEPARTMENT AND THE WOUND AND STOMA CLINIC.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 23450819 ↗
• MalfunctionApr 23, 2024No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING RADIOFREQUENCY ABLATION OF LIVER MASS, THE SURGEON PERFORMED ROUTINE OPERATIONS AND FOUND THAT THE FLUSHING PIPELINE WAS NOT SMOOTH DURING USE, WATER CIRCULATION COULD NOT BE CARRIED OUT. STOPPED USING IT AND REPLACED IMMEDIATELY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19168830 ↗
• MalfunctionApr 19, 2024No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD DIFFERENCE RF (RADIO FREQUENCY) INLET PIPES AND WATER WOULD NOT CIRCULATE. THE PROCEDURE CAN BE COMPLETED BY LEVERAGING NEW DEVICES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19146779 ↗
• MalfunctionJun 29, 2022Device Damaged Prior to Receipt by User; Detachment of Device or Device Component; Device Damaged Prior to Receipt by User; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE OPERATING DOCTOR FOUND THAT THE TEMPERATURE OF THE ABLATION NEEDLE DID NOT RISE, HE STOPPED THE ABLATION AND CHANGED TO A NEW PRODUCT. ONE DEVICE WAS BROKEN INSIDE WHEN OPENED. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE RFA NEEDLE WAS COMPLETELY SEVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14856148 ↗
• MalfunctionJan 26, 2022Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, FREQUENCY PIN OPERATION IS UNSTABLE (POWER FLUCTUATED UP AND DOWN). THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359068 ↗
• MalfunctionDec 14, 2021No Flow; No Flow

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE WATER CANNOT GO THROUGH THE WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006715 ↗
• MalfunctionNov 2, 2021Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE DEVICE TEMPERATURE SUDDENLY HIGH AND LOW, INTERMITTENT JUMP STOP. THEY USE ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737926 ↗
• MalfunctionJul 12, 2021No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WATERLINE BROKE. SIMILAR DEVICE WAS USED TO CONTINUE/FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150989 ↗
• MalfunctionMay 17, 2021No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING RADIOFREQUENCY ABLATION OF LIVER TUMOR, THE DEVICE HAD CIRCULATION ISSUE. FAILED TO CIRCULATE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837605 ↗
• MalfunctionNov 19, 2020No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE HAD A PIPE BLOCKAGE. THEY REPLACED THE NEEDLE TO RESOLVE THE ISSUE AND TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10869109 ↗
• MalfunctionSep 16, 2020Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THE NEEDLE TEMPERATURE NOTATION WAS UNSTABLE. IT WAS REPLACED AND THE PROCEDURE WAS FINISHED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540882 ↗
• InjuryJul 21, 2020Failure to Deliver Energy; No Flow; Failure to Deliver Energy; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD A CIRCULATION PROBLEM WHEREIN IT WAS UNABLE TO LOOP AND NO ENERGY OUTPUT. THE PROCEDURE WAS ABORTED.

  Patient problems: No Code Available

  MAUDE report 10305204 ↗
• MalfunctionJan 3, 2020Leak/Splash; No Flow; Leak/Splash; No Flow

  ACCORDING TO THE REPORTER, DURING ABLATION, THE DEVICE HAD A CIRCULATION ISSUE WHEREIN LEAKS WERE PRESENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547671 ↗
• InjuryDec 12, 2019Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE ABLATION LEAD DID NOT HAVE ENOUGH ENERGY OUTPUT TO DESTROY THE TUMOR. ANOTHER DEVICE WAS USED AND IT WORKED FINE. THE PROCEDURE HAD BEEN COMPLETED.

  Patient problems: No Code Available

  MAUDE report 9459865 ↗
• InjuryDec 11, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE WHEREIN THE PROCEDURE WAS ABORTED.

  Patient problems: No Code Available

  MAUDE report 9450109 ↗
• MalfunctionOct 22, 2019No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE WATER PIPE OF SYSTEM PUMP WOULD NOT START UP TO CAPTURE WATER TO DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217830 ↗
• InjuryOct 15, 2019Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT ACTIVATE WHEN IT WAS INSERTED INTO THE TUMOR SITE. THE PROCEDURE WAS ABORTED.

  Patient problems: No Code Available

  MAUDE report 9191373 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, DURING THE CONTROL TOMOGRAPHY, THE DOCTOR SAW A PIECE OF METAL IN THE LIVER IN THE ABLATION AREA. HE CHECKED THE NEEDLE AND IT WAS FINE BUT THE PROBLEM IS THAT HE DISCARDED THE NEEDLE.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended

  MAUDE report 9121098 ↗
• MalfunctionSep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER RADIOFREQUENCY ABLATION, THE SKIN ON THE RIGHT THIGH OF THE PATIENT WAS RED, ONE 1CENTIMETER(CM)X4CM, AND TWO 1 CM X 1 CM BLISTERS APPEARED, AND HAD MILD SKIN BURN.

  Patient problems: No Code Available; Skin Discoloration

  MAUDE report 9106898 ↗
• MalfunctionAug 26, 2019Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE WATER WAS FLUSHED THE TEMPERATURE WENT TO LL. EVEN WHEN THE WATER WAS STOPPED, THE TEMPERATURE INDICATION STAYED IN LL. THE NEEDLE WAS REPLACED. THE TEMPERATURE WAS INDICATED ON THE NEEDLE AFTER REPLACEMENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8931558 ↗
• MalfunctionJun 18, 2019Temperature Problem; Intermittent Energy Output; Temperature Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING ABLATION, THE DEVICE'S TEMPERATURE WAS TOO HIGH, THERE WAS NO EFFECTIVE POWER AND IT STOPPED AUTOMATICALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708220 ↗
• MalfunctionFeb 13, 2019Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, UNIT HAD HIGH IMPEDANCE. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8335210 ↗
• MalfunctionJan 22, 2019Device Alarm System; Temperature Problem; Device Alarm System; Temperature Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE UNIT HAD TEMPERATURE SENSOR ERROR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267663 ↗