Arthrex® AR-3200-0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888867351189), received between Nov 30, 2021 and Mar 13, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Failure to Power Up

  ON (B)(6), A FACILITY REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT AN AR-3200-0025 ARTHREX SYNERGY ID CCU LIGHT SOURCE OUTPUT WENT OUT AND WOULD NOT POWER ON DURING A CASE. THEY HAD TO SWITCH TO A NEW UNIT MID-PROCEDURE WITH NO ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591160 ↗
• MalfunctionMay 29, 2025Overheating of Device; Overheating of Device

  ON 05/09/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3200-0025 ARTHREX SYNERGY ID CCU LIGHT CORD CONNECTION BEGAN TO SMOKE WHEN THE LIGHT SOURCE WAS ACTIVATED. THEY WERE USING A STORZ CORD AND STORZ CONNECTION ON THE CCU. A MOBILE CART WAS WHEELED IN AND SET UP, WITH ROUGHLY A 15-MINUTE SURGICAL DELAY WITH THE PATIENT IN THE ROOM. NO HARM TO THE PATIENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107000 ↗
• MalfunctionJan 13, 2025Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0025 CAMERA CONTROL UNIT HAS ISSUES WITH CAMERAS GLITCHING. IT LOOKS LIKE THE METAL RECEIVER FOR THE CAMERAS IS VERY BEAT UP. THIS WAS DISCOVERED DURING A CASE. THE CAMERA WAS CORD WAS HELD IN POSITION CLOSE TO THE BOX SO THERE WAS MINIMAL DISRUPTION. NO PATIENT HARM AND MINIMAL CASE DELAY. AT THE END OF THE CASE THE BOX WAS SWAPPED OUT SO THERE WOULDN¿T BE ANY FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137744 ↗
• MalfunctionDec 30, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE CONSOLE NO LONGER OUTPUTS AN IMAGE VIA DVI (BLACK IMAGE WITH CAMERA HEAD PULLED OUT). THE CONSOLE ALSO DOES NOT SEND A SIGNAL TO THE TABLET (TABLET DOES NOT BOOT UP AND DOES NOT SHUT DOWN WHEN IT RUNS OUT OF POWER, DESPITE CORRECT CONFIGURATION). TABLET STILL STARTS MANUALLY, SCREEN INPUT IS CORRECT, WHICH INDICATES THE CONSOLE.

  Patient problems: Insufficient Information

  MAUDE report 21035635 ↗
• MalfunctionSep 10, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A SURGERY THE CCU OF THE DEVICE THE AR-3200-0025 (B)(6) SUDDENLY HAD NO POWER SUPPLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181162 ↗
• MalfunctionJun 27, 2024Smoking; Smoking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE DEVICE HAS STARTED TO SMOLDER AT THE LIGHT SOURCE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITHOUT THE 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 19624170 ↗
• MalfunctionJun 19, 2024Intermittent Loss of Power; Intermittent Loss of Power

  ON 05/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06577733 THAT AN AR-3200-0025 SYNERGY CCU'S LED LAMP WENT OUT DURING A PROCEDURE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568519 ↗
• MalfunctionJun 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 05/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0025 CCU CONSOLE SCREEN WENT BLACK. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568428 ↗
• MalfunctionJan 4, 2024Device Emits Odor; Device Emits Odor

  ADDITIONAL INFORMATION RECEIVED ON 1/4/2023: PER REP: "THIS INCIDENT OCCURRED BEFORE THE CASE BEGAN. THE CCU WAS TURNED ON WITH NO CAMERA PLUGGED INTO IT AND IT WAS EMITTING A BURNING SMELL. ONE OF THE HOSPITAL EMPLOYEES NOTICED WHERE THE SMELL WAS COMING FROM AND TURNED THE CCU OFF. THE EMPLOYEE CALLED ME AND THE BIOMEDICAL ENGINEERING DEPARTMENT, AND I RESOLVED THE ISSUE BY REPLACING IT WITH A CCU FROM A ROOM THAT WAS NOT CONDUCTING LAPAROSCOPIC CASES. I THEN CALLED IN THE ISSUE TO ARTHREX SUPPORT AND GOT A REPLACEMENT SENT THAT SAME DAY. THERE WAS NO INJURY OR HARM TO THE FACILITY'S PATIENT, SURGEON, OR STAFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445799 ↗
• MalfunctionNov 29, 2023Moisture Damage; Moisture Damage

  ON 11/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0025 CCU WAS FRIED, AS WATER WAS SPILLED ON CCU IT WOULD NOT TURN ON AT ALL. THIS WAS DISCOVERED BEFORE USE WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229471 ↗
• MalfunctionOct 13, 2023No Display/Image; Defective Device; No Display/Image; Defective Device

  ON 19TH SEPTEMBER 2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-3200-0025 WAS NOT RECORDING VIDEO WHEN TRIGGERED FROM CAMERA OR FROM TABLET DIRECTLY. IT WAS TESTED WITH DIFFERENT CAMERA HEADS AND FAULT REMAINS. THIS WAS DETECTED AT AN UNSPECIFIED TIME.

  Patient problems: Insufficient Information

  MAUDE report 17932534 ↗
• MalfunctionOct 6, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 9/07/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3200-0025 SYNERGY CONSOLE IS HAVING AN ISSUE. ALL OF THE MONITORS WENT BLACK FOR TWO SECONDS AND DID NOT FAIL OVER DURING A CASE. THE PATIENT WAS NOT AFFECTED. THE REP TESTED THE UNIT FOR OVER AN HOUR AND COULD NOT DUPLICATE THE ISSUE. FIELD SUPPORT PERFORMED AN IN-SERVICE. OBSERVED CASES AND TESTED EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890346 ↗
• MalfunctionOct 6, 2023Unexpected Shutdown; Unexpected Shutdown

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06025454 THAT AN AR-3200-0025 CCU SCREEN KEEPS TURNING ON AND OFF EVEN IN SDI. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886576 ↗
• MalfunctionSep 5, 2023Connection Problem; Connection Problem

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-3200-0025 CCU HAD A LOSING SIGNAL WHEN CONNECTED TO THE MONITORS. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685730 ↗
• MalfunctionAug 18, 2023Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Image Display Error/Artifact

  ON 07/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0025 CCU HAS HORIZONTAL LINES. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576699 ↗
• MalfunctionJul 28, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON(B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0025 CCU IS PRODUCING GREEN LINES ON ONE DISPLAY. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17417445 ↗
• MalfunctionJun 13, 2022Melted

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A SURGEON WAS HOLDING A LIGHT CORD AS IT MELTED THROUGH THE SURGEON'S GOWN AND PARTIALLY INTO THE LEAD VEST UNDERNEATH. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 5/26/2022: THIS WAS DISCOVERED DURING A LEFT EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY POSSIBLE CYSTOSCOPY RETROGRADE PYELOGRAM ON (B)(6) 2022. THERE WAS NOT HARM TO PATIENT NOR THE SURGEON, AS THE ISSUE WAS NOTICED WHEN THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676886 ↗
• MalfunctionJun 6, 2022Thermal Decomposition of Device; Overheating of Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-3200-0025 CCU IS OVERHEATING. THIS OCCURRED DURING AN UNKNOWN TIME WHEN THE LIGHT CORD WAS PLUGGED IN IT BURNED THE STERILE DRAPE IN JUST A FEW SECONDS. THE LIGHT POST GETS EXTREMELY HOT ALMOST INSTANTLY. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603333 ↗
• MalfunctionJan 31, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0025 SYNERGY CONSOLE WAS USED IN A CASE AND THE PATIENT HAD A CIRCULAR BURN. THIS BURN WAS DISCOVERED FROM A 2 WEEK POST-OP FOLLOW UP EXAM. THE PROCEDURE WAS A GASTRIC BYPASS ON A FEMALE PATIENT ON (B)(6) 2021.

  Patient problems: Burn(s)

  MAUDE report 13396735 ↗
• MalfunctionDec 27, 2021Overheating of Device

  ON 12/07/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0025 SYNERGY CONSOLE WAS INVOLVED IN CASE WHEN A PATIENT WAS BURNED. ADDITIONAL INFORMATION PROVIDED 12/09/2021: THE CASE WAS FINISHED AS PLANNED WITH NO KNOWN INCIDENT. APPROXIMATELY 15 MINUTES POST OP, IT WAS BROUGHT TO OUR ATTENTION VIA THE SURGICAL TECH IN THE ROOM THAT THE PATIENT HAD SUSTAINED A BURN INJURY AND THEY BELIEVED IT TO BE DUE TO THE HEAT LEVEL OF OUR LIGHT CORD / LIGHT POST CONNECTION.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 13087716 ↗
• MalfunctionNov 30, 2021No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAS NO SIGNAL. NO ADDITIONAL INFORMATION REGARDING A SPECIFIC FAILURE MODE WAS PROVIDED. THE PROBLEM WAS NOTICED BEFORE THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE ABOVE 08-NOV-2021: IT WAS REPORTED THAT DURING A LAPAROSCOPY SURGERY THE MONITOR 32HL710S-W (SN (B)(4)) WENT BLACK FOR 10 MINUTES DURING THE SURGERY AND IT DID NOT FIND ANY SIGNAL, NEITHER DP NOR SDI. IT WAS CONFIRMED THAT AFTER REPLACING THE MONITOR AFTERWARDS THE ERROR PERSISTED WITH THE NEW MONITOR. AFTER THE CONSOLE AR-3200-0025 (SN (B)(4)) WAS REPLACED THE ERROR DID NOT OCCUR AGAIN. ACCORDING TO THIS TEST THE CONSOLE WAS CAUSING THE ERROR. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY, BUT THE SURGICAL TECHNIQUE HAD TO BE SWITCHED TO AN OPEN SURGERY. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Laceration(s)

  MAUDE report 12895158 ↗