Cool-tip ACT1530Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884524000947), received between Mar 4, 2017 and Dec 30, 2021 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Overheating of Device; No Flow; Overheating of Device; No Flow

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE DEVICE WAS TEMPERATURE COULDN'T GO DOWN, THERE WAS NO WATER CIRCULATION. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119112 ↗
• MalfunctionNov 19, 2021No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE SALINE CANNOT PASS IN THE NOZZLE OF THE NEEDLE BECAUSE IT WAS CLOGGED. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843103 ↗
• MalfunctionAug 28, 2020Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, AT THE BEGINNING OF THE CASE, THE NEEDLE TEMPERATURE WAS NORMAL, BUT AFTER IT WAS INSERTED, THE NEEDLE TEMPERATURE ROSE, AND THE PATIENT REPORTED PAIN. AFTER THE NEEDLE WAS PULLED OUT, THEY OBSERVED THAT THERE WAS SOMETHING SIMILAR TO OXIDATION ON THE TIP. THEY REPLACED THE NEEDLE AND THE TEMPERATURE WAS NORMAL, AND THE PATIENT REPORTED NO DISCOMFORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10464164 ↗
• MalfunctionApr 9, 2019Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, POST PROCEDURE, THE GENERATOR'S TEMPERATURE SCREEN ONLY SHOWED "LL" AND NOT A REAL TEMPERATURE WHEN ANTENNA WAS CONNECTED. A NEW ANTENNA WAS USED AND THE TEMPERATURE WENT FINE. THERE WAS NO PATIENT INJURY. A PHOTO SHOWING THE ABLATION GENERATOR SHOWING "LL" SIGN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497646 ↗
• MalfunctionSep 5, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE GENERATOR, PUMP AND TUBE WERE PROPERLY CONNECTED BUT SINGLE ELECTRODE DID NOT WORK AT ALL. IN PANEL, THERE WAS NO MEASUREMENT OF TEMPERATURE, CURRENT AND WATT DURING PROCEDURE. THEY CHANGED FOR A NEW PRODUCT WITH A DIFFERENT LOT NUMBER IN ORDER TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT. INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE SOLDER JOINT AT THE TIP OF THE THERMOCOUPLE WAS FOUND TO BE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848277 ↗
• MalfunctionJul 23, 2018Device Displays Incorrect Message; Temperature Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE ELECTRODE WAS CONNECTED TO THE GENERATOR AND THE PUMP WAS STARTED AND ABLATION WAS PERFORMED. THE TEMPERATURE WAS UNSTABLE AND AN ERROR OCCURRED AFTER FEW SECONDS. THE ELECTRODE WAS REPLACED WITH NEW ONE AND THE NEW ONE WORKED FINE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7710764 ↗
• MalfunctionMay 24, 2018Ambient Temperature Problem; Ambient Temperature Problem

  ACCORDING TO THE REPORTER, DURING RFA FOR LIVER CANCER, ABLATION WAS ATTEMPTED BUT THE TARGET LESION DID NOT SEEM TO BE ABLATED; ABLATION WAS ATTEMPTED FOR 12 MINUTES, BUT STILL NO CHANGE WAS SEEN. THE NEEDLE WAS REPLACED WITH NEW ONE, AND ABLATION WAS SUCCESSFUL. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542438 ↗
• MalfunctionMay 17, 2018Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE TIP CANNOT HEAT OUT THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7522853 ↗
• MalfunctionJan 18, 2018Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE¿S HEATING TEMPERATURE VARIES GREATLY AND UNABLE TO HEAT THE NEEDLE. THERE WAS NO PATIENT INJURY AND COMPLICATION ASSOCIATED WIT THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7202920 ↗
• MalfunctionSep 8, 2017Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, BEFORE THE PROCEDURE OF RADIO ABLATION, THEY NOTICED THE TEMPERATURE DROPPING TO 10 ° C OR LL (LOW LOW) AFTER THE PRIME, WHICH WAS THE TEMPERATURE DEFERRED. IT WAS AT THAT MOMENT THAT THE ELECTRODE PRESENTED A PROBLEM. DURING THE PRIMING, THE DEVICE HAD ITS TEMPERATURE READER WITH ABNORMAL BEHAVIOR, AS CAN BE SEEN IN THE ATTACHED VIDEO, BUT INSTEAD OF THE TEMPERATURE DISPLAY STAY AT 10 ° C OR LL AS EXPECTED, THE TEMPERATURE REACHED HH (HIGH HIGH), TEMPERATURE THAT WAS ABNORMAL SINCE THE ELECTRODE WAS NOT ACTIVE AND THERE WAS NO POSSIBILITY OF THAT TEMPERATURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6852864 ↗
• MalfunctionApr 20, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TEMPERATURE WAS ABNORMAL DURING USE. THERE WAS NO PATIENT HARM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6508639 ↗
• MalfunctionMar 9, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TEMPERATURE WAS ABNORMAL AND THERE WAS NO OUTPUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6391011 ↗
• MalfunctionMar 8, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THE PRODUCT WAS CONNECTED TO THE GENERATOR AND THE TEMPERATURE DISPLAYED AS 99 DEGREES. THE PRODUCT WAS RECONNECTED TO THE GENERATOR SEVERAL TIMES BUT THE INCIDENT WAS DUPLICATED. THERE WAS NO PATIENT HARM. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6388062 ↗
• MalfunctionMar 4, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE DEVICE COULD NOT SENSE THE CORRECT TEMPERATURE AND THE TEMPERATURE WAS FLUCTUATING ON THE MONITOR. THE ISSUE WAS FOUND PRIOR TO USE AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378662 ↗