Arthrex® AR-3210-0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867197053), received between Dec 21, 2021 and Jun 20, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2024Overheating of Device; Overheating of Device

  ON 10/13/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3210-0025 4K HD C-MOUNT CAMERA, IS GETTING VERY WARM/HOT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. THE PATIENT WAS NOT AFFECTED. THE CASE WAS COMPLETED USING A DIFFERENT CAMERA. TS: CHECKED THE LIGHT SOURCE OUTPUT, CHANGED OUT THE LIGHT CORD THINKING IT WAS GOING BAD AND ALSO TESTED THE CAMERA AFTER THE CASE IN WHICH IT STARTED HEATING UP AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574205 ↗
• MalfunctionMay 23, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE HAS A PROBLEN WITH OVERHEATING. NO ADDITIONAL INFORMATION REGARDING A SPECIFIC FAILURE MODE WAS PROVIDED. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380939 ↗
• MalfunctionJul 14, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-3210-0025 CAMERA HEADS ARE PRODUCING A YELLOW SCREEN AND ARE UNABLE TO WHITE BALANCE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324927 ↗
• MalfunctionJul 14, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 06/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-3210-0025 CAMERA HEADS ARE PRODUCING A YELLOW SCREEN AND ARE UNABLE TO WHITE BALANCE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324912 ↗
• MalfunctionDec 21, 2021Melted; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 30-NOV-2021: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING THE SURGERY. THE PATIENT WAS NOT INJURED BUT THE CAMERA HEAD WAS SO WARM THAT THE CAMERA DRAPE MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053750 ↗