Arthrex® AR-3200-0001TRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867029163), received between Apr 15, 2020 and Feb 9, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  ON 27TH DEC 2023, ONE AR-3200-0001T DEVICE WAS USED DURING A TRAUMA SURGERY, BUT THE SCREEN DISPLAYED INTERMITTENTLY, WHICH CAUSED A 30-MINUTE DELAY OF THE PROCEDURE AND RESULTED IN INCREASED BLOOD LOSS FROM THE PATIENT. NO ADDITIONAL ANESTHESIA WAS USED DUE TO THE DELAY AND BLOOD LOSS WAS TREATED BY THE SURGEON. THE INSTRUMENT WAS REPAIRED BY THE HOSPITAL DURING THE SURGERY AND CANNOT BE RETURNED RIGHT NOW. THE PATIENT IS WELL NOW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18678066 ↗
• InjuryNov 17, 2023Overheating of Device; Overheating of Device

  ON 10/25/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06066622 THAT AN AR-3200-0001T CONSOLES MONITOR WENT DARK AND THE FIBER WAS HOT. THIS OCCURRED DURING AN ARTHROSCOPIC PATELLAR DISLOCATION PLASTY PROCEDURE ON (B)(6) 2023, WHERE THE PATIENT HAD A SHALLOW SECOND-DEGREE SKIN SCALD WITH AN AREA OF ABOUT 1*0.5 CM AND ULCERATION IN THE ANTERIOR UPPER TIBIAL SEGMENT OF THE LEFT CALF. THERE ARE ALSO TWO DEEP SECOND-DEGREE SKIN SCALDS AND RUPTURING IN THE MIDDLE AND UPPER SEGMENTS, ONE WITH AN AREA OF 1*0.5CM AND THE OTHER WITH AN AREA OF 2*2 CM. THE WOUNDS WERE CAUSED BY HEAT BURNING IN THE FIBER. THE CASE WAS COMPLETED SEVERAL HOURS LATER.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18163097 ↗
• MalfunctionSep 18, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06014189 THAT AN AR-3200-0001T SYNERGY CONSOLE IS HAVING A PROBLEM WITH THE IMAGE ON THE SCREENS DURING ARTHROSCOPIES. WHEN USING THE APOLLO RF BURNER OR OTHER ARTHROSCOPIC ELECTROCAUTERY, THE IMAGE ON THE SCREEN FLICKERS, DISAPPEARS, HAS LINES RUNNING THROUGH IT, OR IS OTHERWISE DISTORTED. TECH SUPPORT IS TROUBLESHOOTING TO RESOLVE THE ISSUE. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763494 ↗
• MalfunctionAug 18, 2023No Display/Image; Image Display Error/Artifact; No Display/Image; Image Display Error/Artifact

  ON 07/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0001T CCU IS NOT SHOWING AN IMAGE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576985 ↗
• MalfunctionSep 26, 2022Failure to Power Up; Sparking

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3200-0001T CCU PRODUCED SPARKS FROM THE BACK AND WAS UNABLE TO POWER ON AFTER THE INCIDENT. NO CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484387 ↗
• MalfunctionApr 15, 2020Connection Problem

  THE DEVICE WAS RECEIVED BY ARTHREX (B)(4) FROM THE CUSTOMER WITH A NOTE THAT STATED ¿TOWER DOES NOT MAKE A CONNECTION". THE PROBLEM WAS NOTICED DURING THE SURGERY. NO FURTHER INFORMATION RECEIVED. ADDITIONAL INFORMATION OBTAINED 24-MAR-2020: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A KNEE ARTHROSCOPY. THE PATIENT WAS ALREADY IN THE SURGERY ROOM AND PREPARED FOR THE SURGERY BUT DUE TO THE REPORTED ISSUE THE SURGERY WAS CANCELLED. A SECOND SURGERY IS PLANNED BUT DUE TO THE COVID-19 SITUATION THE SURGERY DATE IS UNCLEAR. ADDITIONAL INFORMATION OBTAINED 09-APR-2020: THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN IT WAS NOTICED THAT DEVICE DID NOT WORK. THE HOSPITAL DID NOT HAVE AN REPLACEMENT SYSTEM ON SITE AND READY FOR USE.

  Patient problems: No Code Available

  MAUDE report 9963496 ↗