Cool-tip ACT1520Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884524001180), received between Mar 1, 2017 and Apr 14, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026No Flow; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AND WAS ABORTED DUE TO THE DEVICE FAILED TO CIRCULATE.

  Patient problems: Insufficient Information

  MAUDE report 24872964 ↗
• MalfunctionJun 3, 2025No Flow; No Flow

  IT WAS REPORTED THAT THE DEVICE FAILED TO CIRCULATE DURING THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A NEW DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131635 ↗
• MalfunctionAug 28, 2024Overheating of Device; No Flow; Overheating of Device; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE CONSUMABLE COULD NOT BE WATER CIRCULATED AND THE ABLATION NEEDLE OVERHEATED. THE PHYSICIAN REPLACED THE DEVICE AND CONTINUED THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20090654 ↗
• MalfunctionDec 17, 2021Material Discolored; Device Damaged Prior to Receipt by User; Adverse Event Without Identified Device or Use Problem; Material Discolored; Device Damaged Prior to Receipt by User; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE AFTER OPENING THE PACKAGE, IT BECAME MOLDY AND OXIDIZES AND TURNED BLACK. THE PROCEDURE WAS CANCELLED THE PATIENT WAS NOT UNDER ANESTHESIA AND SCHEDULED THE NEXT DAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024723 ↗
• MalfunctionSep 21, 2021Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, EVEN WHEN THE NEEDLE WAS CONNECTED, THE TEMPERATURE FLUCTUATED. NO PROBLEM WAS DETECTED IN THE PROCEDURE ITSELF BECAUSE THE DEVICE MOVED WITHOUT ANY PROBLEMS WHEN A DIFFERENT NEEDLE WAS CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506775 ↗
• InjuryJul 1, 2019No Apparent Adverse Event; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING ABLATION, THE ANTENNA WAS NORMAL DURING USE, THE RANGE OF THE ABLATION HAD BEEN IN 2.6CM AND 2.3CM (LENGTH AND WIDTH) IN ACCORDING THE ORIGINAL INFORMATION. BUT THIS EVENT WAS ABNORMAL BECAUSE THE RESULT OF TREATING THE TUMOR DID NOT REACH THE ABLATION RANGE OF THE PRODUCT. THE DOCTOR WILL ABLATION AGAIN IN ANOTHER TIME FOR THE PATIENT. AN IMAGE WAS PROVIDED WITH DETECTED TUMOR.

  Patient problems: No Code Available

  MAUDE report 8750722 ↗
• MalfunctionJun 18, 2019No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING A LIVER TUMOR ABLATION AND AFTER THE PUNCTURE, THE WATER CIRCULATION WAS BLOCKED. THEY REPLACED THE PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708282 ↗
• InjuryApr 22, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING ABLATION, THE DEVICE HAD NO POWER NOR ENERGY DELIVERY. THE SAME MACHINE REPEATEDLY TURNED ON SEVERAL TIMES, SHOWING THE SAME PROBLEM, AND AFTER REPLACING A NEW SET OF ELECTRODE NEEDLES, IT RETURNS TO NORMAL. THE PROCEDURE WAS ABORTED.

  Patient problems: No Code Available

  MAUDE report 8537045 ↗
• MalfunctionDec 18, 2018No Flow; No Flow

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE CIRCULATING WATER PIPES ARE NOT SMOOTH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176554 ↗
• MalfunctionDec 18, 2018Device Alarm System; Temperature Problem; Device Alarm System; Temperature Problem

  ACCORDING TO THE REPORTER, DURING ABLATION, THE DEVICE HAD AN ALARM PROBLEM SHOWING AN EXCESSIVE TEMPERATURE. REPLACED THE NEW NEEDLE AND CONTINUED WITH THE SURGERY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 8176527 ↗
• InjuryMay 9, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE ELECTRODE WAS SET ACCORDING TO THE MANUAL. IT WAS ACTIVATED BUT THE UNIT WOULD NOT START AND AN ¿IMPEDANCE OVER¿ ERROR WAS DISPLAYED REPEATEDLY. THE PROCEDURE WAS CANCELLED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6554333 ↗
• MalfunctionApr 4, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THE TEMPERATURE WAS NOT DISPLAYED AFTER PUNCTURING. THERE WAS NO PATIENT HARM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6457050 ↗
• MalfunctionMar 1, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, TEMPERATURE WAS NOT SHOWN ON THE DISPLAY UPON CONNECTING SUBJECT NEEDLE TO THE GENERATOR. ANOTHER NEEDLE WAS USED TO COMPLETE THE CASE. NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6368415 ↗