COOLIEF* Cooled RF Advanced-R Generator CRG-ADVANCED-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193493473038), received between Mar 17, 2021 and Mar 17, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A COOLIEF PROCEDURE WAS PERFORMED ON A PATIENT, WHERE TWO LESIONS WERE CREATED FOR THE TREATMENT OF HIP PAIN. DURING THE PROCEDURE, THE PATIENT WAS "UNCOMFORTABLE AND SWEATING SOMEWHAT." A FEW DAYS LATER, THE PATIENT STARTED EXPERIENCING PAIN, NUMBNESS, AND WEAKNESS IN THE RIGHT LEG, AND A TEMPERATURE OF 99 DEGREES FAHRENHEIT. THE PATIENT VISITED A PHYSICIAN WHO "PRESCRIBED MEDICATIONS." AFTER A FEW WEEKS THE PAIN HAD NOT RESOLVED, SO THE PATIENT VISITED THE EMERGENCY ROOM AND RECEIVED A MRI. "THE MRI RESULT SHOWED OSTEOMYELITIS AT THE FEMORAL JOINT. PATIENT THEN HAD SURGERY FOR DEBRIDEMENT OF THE AFFECTED JOINT. DURING SURGERY THERE WERE NO VISIBLE SIGNS OF DRAINAGE OR INFECTION. A CULTURE WAS TAKEN FOR LABS AND SHOWED SKIN STAPHYLOCOCCUS. THE PATIENT WAS THEN PRESCRIBED ANTIBIOTICS FOR 6 WEEKS. PREVIOUS TO THE COOLIEF PROCEDURE THE PATIENT HAD AN INTERARTICULAR STEROID INJECTION TO THE JOINT OF THE AFFECTED HIP. HIS HIP PAIN HAD INCREASED PRIOR TO THE COOLIEF PROCEDURE."

  Patient problems: Fever; Muscle Weakness/Atrophy; Numbness; Osteomyelitis; Pain

  MAUDE report 11504093 ↗

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