OsteoCool™ 2.0 RF Ablation System OC01-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000764005), received between Nov 3, 2025 and Sep 1, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Display or Visual Feedback Problem

  Information was received from a manufacturer representative regarding a device used for a Spinal therapy. It was reported that the generator would not register the hub as connected. Multiple hubs were tried, all with the same result. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received as the device has been used with no issues multiple times.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50535503 ↗
• MalfunctionDec 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENT HAVING AN F25 ERROR AS SOON AS THEY POWERED ON PRIOR TO PROCEDURE. REBOOTED TRIED DIFFERENT OUTLETS ISSUE PERSISTED. NO PATIENT HARM REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776100 ↗
• MalfunctionNov 3, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN OSTEOCOOL GENERATOR. IT WAS REPORTED THAT GENERATOR WAS DAMAGED. THE GENERATOR WAS NOT RECOGNIZING THE HUB WHEN PLUGGED IN. TRIED 3 DIFFERENT HUBS AND ¿ERROR 51 INVALID HUB¿ WAS THE MESSAGE.HUB WAS UNPLUGGED MULTIPLE TIMES IN ORDER TO GET IT TO WORK. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452568 ↗