Arthrex® AR-9800Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00888867142473), received between Mar 14, 2019 and Sep 8, 2026 — classified as 7 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Power Conditioning Problem

  On 24-Aug-2026, it was reported by a sales Representative via (b)(4) that an AR-9800 console experienced a power surge that cause an ablator to begin burning tissue instead of ablating. Noticed during a case with no patient effect.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667825 ↗
• MalfunctionJun 10, 2026Device Emits Odor; Failure to Power Up

  ON 22-MAY-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9800 SYNERGY RF CONSOLE PRODUCED A BURNING SMELL AND WOULD NOT POWER ON. NO CASE WAS INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 25457206 ↗
• MalfunctionApr 16, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY THE TIP OF THE DEVICE BURNED AND CAUSING SMOKE COMING OUT OF THE ARTHROSCOPIC PORTALS. IT WAS FURTHER REPORTED THAT THE TIP OF THE DEVICE BECAME COMPLETELY BLACK. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION ABOUT THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896080 ↗
• MalfunctionApr 16, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY THE TIP OF THE DEVICE BURNED AND CAUSING SMOKE COMING OUT OF THE ARTHROSCOPIC PORTALS. IT WAS FURTHER REPORTED THAT THE TIP OF THE DEVICE BECAME COMPLETELY BLACK. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION ABOUT THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895613 ↗
• MalfunctionDec 30, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE CHANGED POWER LEVELS BY SWITCHING FROM 7 TO 9 ON ITS OWN. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23925915 ↗
• MalfunctionDec 8, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF SURGERY THE DEVICES AR-9800 (SN: (B)(6), A PROBE AR-9831 AND AN ARTHROSCOPE FROM ANOTHER MANUFACTURER WERE USED. ALTHOUGH THERE WAS NO CONTACT BETWEEN THE PROBE AND THE SCOPE, THE SCOPE GOT DAMAGED. THE SCOPE GOT COMPLETELY BLACKED OUT, INCLUDING A BLACK LINE ACROSS THE OPTICS. THE SETTING WAS CORRECT; AR-9831 WAS USED WITH SETTING 7 / 1. 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. UPDATE AVOE 21-NOV-2025 ACCORDING TO THE FIELD TECHNICIAN THE CONSOLE WAS MOST LIKELY NOT GROUNDED DURING USE AS IT SHOULD HAVE BEEN. THE GROUNDING CABLE WAS NOT CORRECTLY POSITIONED WHEN THE DEVICE WAS REMOVED FROM THE TOWER BY THE ARTHREX FIELD SERVICE. THE DEVICE WAS INITIALLY ADDED TO THE TOWER BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741707 ↗
• InjurySep 19, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED AFTER THE ANKLE JOINT ARTHROSCOPY THAT THE PATIENT SUFFERED BURNS AT AN ARTHROSCOPY PORTAL, RESULTING IN NERVE DAMAGE. THIS WAS DETERMINED BY A PLASTIC SURGEON. DUE TO THIS INJURY, A SKIN GRAFT IS NECESSARY. THE ANKLE ARTHROSCOPY WAS PERFORMED USING AN OPTICAL DEVICE AND AN AR-9845. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Burn(s)

  MAUDE report 23099881 ↗
• MalfunctionJun 19, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY THE PATIENTS ARM WAS JOLTING WHEN USING THE RF WAND. SURGEON AND STAFF NOTED SOMETIMES HAVING TO HOLD THE ARM DOWN. THE SURGEON CONTINUED TO USE THE DEVICE AS IT NOT CONSTANTLY HAPPENED BUT THE ARM KEPT JOLTING. 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 AVOE 27-MAY-2025 IT WAS FURTHER REPORTED THAT DIFFERENT SETTINGS (5&1 AND 7&1) WERE TRIED AND DID NOT MAKE TOO MUCH DIFFERENCE WITH THE SPASMS. IN REGARD TO NEAR MUSCLE THE SURGEON COULD NOT SEE A PATTERN WITH THE SPASMS AS THEY WERE INFREQUENT. THE PART AND SERIAL NUMBER OF THE CONSOLE AR-9800 (SN: (B)(6) WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292047 ↗
• 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 (B)(4) 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 22286309 ↗
• MalfunctionJun 17, 2025Radiofrequency Interference (RFI); Unintended Electrical Shock; Radiofrequency Interference (RFI); 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. 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. UPDATE CMACKENBACH 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 22235600 ↗
• MalfunctionMar 20, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT WHILE ENTERING PATIENT DATA BEFORE THE OPERATION, SMOKE CAME OUT OF THE BIPOLAR ABLATOR CONSOLE. THE CAPACITOR ON THE CONSOLE BOARD WAS BURNED OUT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653079 ↗
• MalfunctionJan 14, 2025Device Emits Odor; Noise, Audible; Device Emits Odor; Noise, Audible

  ON 12/18/2024, A FACILITY REPRESENTATIVE REPORTED VIA SEMS-06738073 THAT AN AR-9800 SYNERGY RF CONSOLE HAD A POP SOUND AND SMELLED SMOKE, AND AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE HAD A HANDPIECE ERROR MESSAGE DISPLAYED. NO PATIENT WAS AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148612 ↗
• MalfunctionSep 18, 2024Overheating of Device; Overheating of Device

  ON 08/15/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT AN AR-9800 SYNERGY RF CONSOLE WAS OVERPOWERING THE ABLATOR AND MELTING IT. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE ON (B)(6) 2024: THE ABLATOR USED WITH THE CONSOLE WAS AR-9821 APOLLORF XL90, ASPIRATING ABLATOR. THE REP STATED THAT THE AR-9821 APOLLORF XL90, ASPIRATING ABLATOR LOOKED LIKE IT WAS OVERHEATING, AND THE SURGEON NOTICED THAT THE ABLATOR WAS RUNNING TOO STRONG AND THEN SAW THE OUTSIDE OF THE METAL PIECE OF THE ABLATOR TOWARDS THE PLASTIC PART WAS BURNING BUT NOT NECESSARILY MELTING IT. AR-9800 SYNERGY RF CONSOLE HAD NO ERROR MESSAGES BEFORE OR DURING THE PROCEDURE, AND THE DEVICE DID NOT STOP THE ABLATOR WHEN THIS WAS NOTICED. THERE WAS NO REPORT OF SMOKE OR A BURNING SMELL. THERE WAS NO CASE DELAY, AND THE CASE WAS COMPLETED USING A SHAVER HANDPIECE AND ANOTHER AR-9821 APOLLORF XL90, ASPIRATING ABLATOR, AND AR-9800 SYNERGY RF CONSOLE TO COMPLETE THE CASE SUCCESSFULLY WITH NO ISSUES. NO IMAGES OR VIDEOS WERE TAKEN OF THE ALLEGATION, AND THE ABLATOR WAS DISCARDED AFTER THE CASE. THIS WAS DISCOVERED D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248456 ↗
• MalfunctionSep 17, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE ANTERIOR PART OF THE DEVICE DISINTEGRATED INTO SEVERAL PARTS. ALL PARTS WERE RETRIEVED. 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 20237330 ↗
• MalfunctionSep 3, 2024Overheating of Device; Overheating of Device

  ON 08/08/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-(B)(4) THAT AN AR-9800 SYNERGY RF CONSOLE BURNED. THIS OCCURRED DURING A PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127442 ↗
• MalfunctionAug 26, 2024Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT THE DEVICE BLOWING FUSES. "BURNING" SMELL FROM BACK FAN. THIS WAS NOTED DURING INCOMING INSPECTION. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064089 ↗
• MalfunctionJul 9, 2024Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT THERE WAS A LOUD BANG FROM THE CONSOLE AND IT SMELLS BURNED. THIS WAS NOTICED DURING AN INSPECTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699886 ↗
• MalfunctionJun 28, 2024Loss of Power; Loss of Power

  ON 06/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4). THAT AN AR-9800 SYNERGYRF CONSOLE IS CAUSING AN ISSUE. THIS IS ONE OF FIVE DEVICES THAT ARE LINKED TOGETHER. WHEN PLUGGED IN, ONE OR MORE OF THESE DEVICES CAUSE A LOSS OF POWER FOR ALL INSTRUMENTS USING THAT SAME OUTLET (THEY ARE PLUGGED INTO A MEDICAL GRADE OUTLET ON THE WALL IN THE OR, NOT JUST A POWER STRIP). THE CONTACT IS UNABLE TO FIGURE OUT WHICH CAUSES THE ISSUE; THEREFORE, THEY'D LIKE TO REPLACE THEM ALL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638909 ↗
• MalfunctionJun 11, 2024Decoupling; Decoupling

  ON 02/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9821 APOLLORFS PLUG IS SEPARATING AND THE AR-9800 BOX MAY BE CAUSING THE ISSUE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509102 ↗
• MalfunctionJun 7, 2024Defective Device; Defective Device

  ON 12/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9821 APOLLO RF XL90, ASPIRATING ABLATOR HAD AN ISSUE. DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022, THE AR-9821 APOLLO ASPIRATING ABLATOR WAS MAKING THE SHOULDER TWITCH, MAKING THE AXILLARY NERVE FIRE WHEN IN THE SHOULDER. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 12/29/2022, THE SALES REPRESENTATIVE STATED VIA PHONE THAT THIS CASE OCCURRED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. NO HARM OCCURRED TO THE PATIENT, NO TISSUE WAS BURNED, AND ONLY THE SHOULDER TWITCHED. HE ALSO STATED THAT AN AR-9821 APOLLO RF XL90, ASPIRATING ABLATOR, AND AN AR-9800 SYNERGY RF CONSOLE BOTH WERE INVOLVED IN THAT CASE AND CAUSED THE ISSUE, BUT HE DID NOT HAVE THE SERIAL NUMBER OF THE CONSOLE. THE FACILITY ONLY WANTED TO REPORT THE COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 12/31/2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022. NOTHING OUT OF THE ORDINARY WAS NOTICED WHEN OPENING THE AR-9821 APOLLO. THERE WERE NO ERROR MESSAGES, THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490839 ↗
• MalfunctionJun 7, 2024Defective Device; Defective Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9800 SYNERGY RF CONSOLE AND AN AR-9821 APOLLO RF XL90, ASPIRATING ABLATOR HAD AN ISSUE. DURING AN UNSPECIFIED PROCEDURE, THE AR-9821 APOLLO WAS MAKING THE SHOULDER TWITCH, MAKING THE AXILLARY NERVE FIRE WHEN IN THE SHOULDER. THE SETTINGS WERE 7 ABLATION 1 COAG. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. THE FACILITY JUST WANTED TO RECORD THE COMPLAINT. ON (B)(6) 2022, THE SALES REPRESENTATIVE STATED VIA PHONE THAT THIS CASE OCCURRED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. NO HARM OCCURRED TO THE PATIENT, NO TISSUE WAS BURNED, AND ONLY THE SHOULDER TWITCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022. NOTHING OUT OF THE ORDINARY WAS NOTICED WHEN OPENING THE AR-9821 APOLLO. THERE WERE NO ERROR MESSAGES, THE DEVICE DIDN'T FAIL, THE SHOULDER WAS JUST TWITCHING. THE ABLATOR WAS NOT IN CONSTANT USE, JUST SHORT USES. THE VACUUM/SUCTION SETTING WAS AT FULL, NEPTUNE AT 500. THE ABLATOR DID NOT COME IN CONTACT WITH ANY OTHER DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489018 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED ON 12/17/2021 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9811 PROBE WAS DAMAGED DURING A CASE. THE PATIENT WAS NOT AFFECTED AND THERE WERE NO DELAYS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469075 ↗
• MalfunctionMay 27, 2024Defective Device; Defective Device

  IT WAS REPORTED ON 03/14/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9800 CONSOLE CONNECTION PORT IS BURNT. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400394 ↗
• MalfunctionMay 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, A SALES REPRESENTATIVE VIA (B)(6) REPORTED THAT AN AR-9800 SYNERGY CONSOLE FOOT PEDAL HUB WAS PULLED OUT FROM THE CONSOLE EXPOSING CABLES. CASE/PATIENT INVOLVEMENT NOT INDICATED.

  Patient problems: Insufficient Information

  MAUDE report 19315779 ↗
• MalfunctionApr 25, 2024Melted; Melted

  IT WAS REPORTED THE FRONT PORT ON AR-9800, CONSOLE THE PORT IS MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180983 ↗