Arthrex® AR-9825Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867142572), received between Jan 30, 2019 and Sep 18, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY - LABRAL REPAIR SURGERY THE DEVICE FAILED TO ADEQUATELY ABLATE TISSUE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084640 ↗
• MalfunctionJun 18, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE DEVICE CREATED INTERFERENCE AS SOON AS THE HANDPIECE TOUCHED THE PATIENT'S TISSUE. 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. UPDATE CMACKENBACH: ON 26-MAY-2025 FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT WOULD JUMP WHEN THE SURGEON WAS CUTTING THE CAPSULE. IT HAPPENS SOMETIMES WHEN PASSING A NEARBY NERVE. WHILE WORKING ON THE ARTICULATION, THERE WAS NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286387 ↗
• MalfunctionJun 17, 2025Radiofrequency Interference (RFI); Radiofrequency Interference (RFI)

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE DEVICE CREATED INTERFERENCE AS SOON AS THE HANDPIECE TOUCHED THE PATIENT'S TISSUE. THE FUSES HAVE BEEN CHANGED ALREADY. 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 22235557 ↗
• MalfunctionFeb 29, 2024Arcing of Electrodes; Arcing; Arcing of Electrodes; Arcing

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE PLASMA FIELD FORMED, NOT ONLY AT THE HOOK PROBE, BUT ALSO AT THE ENTIRE TIP OF THE PROBE. THE SURGEON THEN STOPPED USING THE PROBE FOR THE OPERATION BECAUSE IT WAS TOO RISKY FOR HIM. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE NROE 13-FEB-2024: FURTHER INFORMATION REVEALED THAT THE SURGEON USED THE SAME DEVICE TO FINISH THE SURGERY, KNOWING THAT THE PLASMA FIELD WAS LARGER THAN USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807196 ↗
• MalfunctionOct 27, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06051802 THAT AN AR-9825 APOLLORF HOOK, 90° TIP PIERCED THROUGH THE PACKAGING AND WAS NOT STERILE ANYMORE. THIS WAS DISCOVERED WHEN OPENING THE PACKAGE DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022621 ↗
• InjuryDec 27, 2022Energy Output Problem

  IT WAS REPORTED BY LEGAL COUNSEL THAT ON (B)(6) 2020 THE PATIENT INJURED HIS LEFT WRIST WHILE CARRYING LUMBAR. THEREAFTER ON (B)(6) 2020 THE PATIENT UNDERWENT SURGERY ON HIS LEFT WRIST. DURING THE SURGERY THE SURGEON UTILIZED THE AR-9825 WHICH RESULTED IN UNINTENDED BURNS TO THE PATIENT. FOLLOWING THE SURGERY THE PATIENT SUFFERED INJURIES TO MULTIPLE EXTENSOR TENDONS IN OR AROUND HIS LEFT WRIST NEAR THE LOCATION OF THE ORIGINAL SURGERY SITE. ON (B)(6) 2021 THE SURGEON PERFORMED A SECOND SURGERY TO ADDRESS THE TENDON INJURIES. FOLLOWING THE SECOND SURGERY THE PATIENT DEVELOPED AN INFECTION IN HIS LEFT WRIST NEAR THE LOCATION OF THE SURGERY SITE. ON (B)(6) 2021 AN I&D WAS PERFORMED. ON (B)(6) 2021 A SECOND I&D WAS PERFORMED AND SUTURE MATERIAL WAS REMOVED. THE PATIENT WAS REFERRED TO AN INFECTIOUS DISEASE DOCTOR AND ULTIMATELY SOUGHT A SECOND OPINION. ON (B)(6) 2021 A DIFFERENT SURGEON PERFORMED SURGERY TO RECONSTRUCT THE PATIENTS RUPTURED LEFT RING AND SMALL FINGER EXTENSOR TENDONS WHICH WERE ALLEGEDLY INJURED AS A RESULT OF THE INITIAL SURGERY. FINALLY IN (B)(6) 2022 THE SECOND SURGEON PERFORMED ANOTHER SURGERY TO REMOVE SCAR TISSUE AND SHAVE DOWN BONES IN THE PATIENT¿S LEFT WRIST.

  Patient problems: Laceration(s); Loss of Range of Motion; Muscle Weakness/Atrophy; Muscle/Tendon Damage; Pain; Scar Tissue; Superficial (First Degree) Burn; Unspecified Infection

  MAUDE report 16050766 ↗
• InjuryJan 30, 2019Insufficient Heating

  IT WAS REPORTED THAT DURING A PROCEDURE, THE APOLLO RF HOOK, AR-9825, WOULD NOT HEAT UP WHEN ON DEFAULT SETTING. THE FACILITY THEN TRIED TURNING THE APOLLO RF HOOK SETTING HIGHER, AND THE HOOK WOULD NOT HEAT. THE FACILITY THEN OPENED A NEW APOLLO RF HOOK AND THE SAME ISSUE OCCURRED, AS THE APOLLO RF HOOK WOULD NOT HEAT ON EITHER SETTINGS. THE SURGEON THE USED SCISSORS TO CUT ACROSS THE TISSUE DUE TO THE 2 APOLLO RF HOOKS NOT WORKING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8289527 ↗
• InjuryJan 30, 2019Insufficient Heating

  IT WAS REPORTED THAT DURING A PROCEDURE, THE APOLLO RF HOOK, AR-9825, WOULD NOT HEAT UP WHEN ON DEFAULT SETTING. THE FACILITY THEN TRIED TURNING THE APOLLO RF HOOK SETTING HIGHER, AND THE HOOK WOULD NOT HEAT. THE FACILITY THEN OPENED A NEW APOLLO RF HOOK AND THE SAME ISSUE OCCURRED, AS THE APOLLO RF HOOK WOULD NOT HEAT ON EITHER SETTINGS. THE SURGEON THE USED SCISSORS TO CUT ACROSS THE TISSUE DUE TO THE 2 APOLLO RF HOOKS NOT WORKING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8289522 ↗