Arthrex® AR-3200-0026Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867443761), received between Nov 7, 2024 and Jun 1, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A HYSTERECTOMY THE IMAGE GOT BLURRED AS SOON AS COAGULATION WAS STARTED AND SMOKE DEVELOPED. THE FOCUS WAS NOT GOOD IN THOSE MOMENTS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348713 ↗
• MalfunctionJul 9, 2025Overheating of Device; Smoking; Noise, Audible; Overheating of Device; Smoking; Noise, Audible

  ON 06/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-3200-0026 SYNERGY CONSOLE OVERHEATED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. 06/24/2025 ADDITIONAL INFORMATION WAS RECEIVED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT NURSE AND STAFF MEMBERS INVOLVED IN THE CASE HEARD A POPPING SOUND AND WITNESSED SMOKE COME FROM INSIDE THE CCU. THE REP WAS NOT PRESENT AT THE TIME OF THE CASE. THIS WAS DURING THE SAME EVENT AS REPORTED EARLIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461655 ↗
• MalfunctionMar 21, 2025Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT THE DEVICE SMELLS STRONGLY BURNT. THIS WAS NOTICED BEFORE THE SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. UPDATE (B)(4) 21-MAR-2025: FURTHER INFORMATION WAS RECEIVED: THIS WAS NOTICED BEFORE THE SURGERY, HOWEVER, THEY USED THE DEVICE ANYWAY AS THEY COULD NOT DETERMINE WHERE THE BURNING SMELL WAS COMING FROM. IT IS STILL NOT CLEAR WHERE THE SMELL CAME FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663600 ↗
• MalfunctionNov 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 10/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA S(B)(4) THAT AN AR-3200-0026 CCU VISION CONSOLE WENT BLACK AND IS NOT RESPONDING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632826 ↗