COOLIEF* Cooled RF Advanced Generator CRG-ADVANCEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00193493473014), received between Feb 13, 2025 and Sep 23, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K192491); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Patient-Device Incompatibility

  It was reported that during a cervical radiofrequency ablation (RFA) procedure, a patient with a pacemaker/implantable cardioverter-defibrillator experienced asystole approximately 17 seconds after radiofrequency treatment was initiated. Cardiopulmonary resuscitation (CPR) was performed and the patient was successfully resuscitated. The procedure was stopped.Information notes:Patient with Pacemaker implantable cardioverter-defibrillator (ICD). Boston Scientific Pacemaker ICD Representative was contacted prior to procedure. Magnet was given to staff from BostonScientific representative the day before the procedure and was placed on patient pacemaker ICD prior to starting procedure. Grounding Pad placed on Right Flank/Lower Back. The Disposable (or Diros) Trident Radiofrequency Hybrid insulated cannula DTRH length unknown. No issue during Sensory Testing. No issue during Motor Testing.Additional information received 04-Sep-2026 the generator that was used at another location. Magnet placement was verified prior to initiating treatments. At the time of asystole the RFA temperature setting was 80 Celsius.

  Patient problems: Asystole

  MAUDE report 50872969 ↗
• InjuryAug 6, 2026Impedance Problem

  It was reported during a radio frequency ablation (RFA) case "the patient experienced what appeared to be an episode of near asystole. This event occurred during motor testing, prior to treatment delivery, of the genicular nerves; the patient almost went "Asystolic/Flatlined. Anesthetist intervened. Treatment continued, no issues afterwards. Patient was healthy, had no pacemaker."

  Patient problems: Arrhythmia

  MAUDE report 50158914 ↗
• InjuryAug 6, 2026Impedance Problem

  It was reported during a radio frequency ablation (RFA) case "the patient experienced what appeared to be an episode of near asystole." This occurred mid-treatment. In this case, treatment waspaused until the patient recovered, after which the procedure was completed without further issue.

  Patient problems: Arrhythmia

  MAUDE report 50158906 ↗
• MalfunctionAug 5, 2026Impedance Problem

  Patient problems: Arrhythmia

  MAUDE report 50141188 ↗
• MalfunctionMay 28, 2025Difficult to Remove; Sparking; Difficult to Remove; Sparking

  IT WAS REPORTED, DIFFICULTY REMOVING THERAPY CABLE FROM GENERATOR THAT RESULTED IN "SPARK" FROM PORT WHERE THERAPY CABLE CONNECTS. THE CUSTOMER WAS USING STANDARD BLACK CABLE FOR CASE. NO PUMP ON UNIT. THE PATIENT¿S PROCEDURE WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100036 ↗
• MalfunctionFeb 13, 2025Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2025-00018 FOR THE FIRST REPORT. IT WAS REPORTED, "PATIENT REFERRED BY POLE ST HELIER (PSH) FOR RADIOLOGICAL GASTROTOMY ON (B)(6) 2024 IN A PATIENT WITH A NEUROLOGICAL HISTORY (FOLLOWING STROKE). NO IMMEDIATE COMPLICATIONS AFTER GPR ON THE SAME DAY, FOUND ON THE GROUND AT 10:30PM, OVER THE RIGHT BARRIER. FOUND FLAT ON HIS STOMACH. SAID TO HAVE PAIN ABOVE RIGHT EYEBROW. NO REDNESS, HEMATOMA, WOUND OR EDEMA. CALL TO DOCTOR ON CALL: POST-FALL MONITORING: NO PAIN, NO HEMATOMA, NO EDEMA, NO VOMITING. PUPILS SYMMETRICAL AND REACTIVE. CLEAR FOR THE REST OF THE NIGHT. ON (B)(6)2024 MORNING: COMPLAINS OF SHOULDER G-PAIN AT GPR LEVEL ADDITION OF ACUPAN THROUGH CATHETER AT 10AM. AT 10:30 A.M., 2 OUT OF 3 FIXATIONS HAD ALREADY FALLEN OUT. NO HEMATOMA, NO OOZING. RETURN TO POLE ST HELIER. PATIENT'S CURRENT CONDITION: CALL FROM REFERRING PHYSICIAN ON (B)(6) 2024 AS PATIENT PRESENTS WITH ABDOMINAL PAIN WITH GUARDING, BIOLOGICAL INFLAMMATORY SYNDROME. PRESCRIPTION FOR AN EMERGENCY ABDOMINAL

  Patient problems: Abdominal Pain; Inflammation; Peritonitis

  MAUDE report 21378825 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192491. One submission often covers many models, so check the product and lot details in each record.

• Z-2622-2023 · Aug 1, 2023 · Completed
  COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system