Arthrex® AR-9821Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00888867267220), received between Feb 15, 2018 and Sep 3, 2025 — classified as 15 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Break; Break

  ON 08/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9821 APOLLO PROBE GRAY SHAFT AROUND THE WAND BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955864 ↗
• MalfunctionSep 3, 2025Break; Break

  ON 08/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9821 APOLLO PROBE GRAY SHAFT AROUND THE WAND BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955786 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 04/21/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-9821 APOLLORF XL90 RADIO FREQUENCY TIP DETACHES. THIS OCCURRED DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2025 THAT WAS COMPLETED WITH ANOTHER PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 21966817 ↗
• MalfunctionJan 23, 2025Defective Device; Defective Device

  ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9821 APOLLORF XL90 ASPIRATING ABLATOR DISPLAYED A PROBE FAILURE ERROR MESSAGE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219018 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SUBACROMIALE DECOMPRESSION SURGERY THE GRAY SLEEVE ON THE TIP BROKE OFF. THE PIECES BROKE OFF BEFORE THE SURGERY. 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 20300438 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE PLASTIC SLEEVE BROKE AT THE TIP IN THE PATIENT. ALL PARTS COULD BE REMOVED. 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 20300155 ↗
• 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 09/13/2024: 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 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 DISCO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248701 ↗
• MalfunctionJun 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 12/02/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9821 APOLLORF IS FALLING APART, THE "NECK" PORTION STARTED LOSING LAYERS. THIS OCCURRED DURING A CASE, A NEW DEVICE WAS BROUGHT IN AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19573853 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  ON 05/08/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-9821 APOLLORF, AND (2) AR-9815 APOLLORF WHEN PLUGGED INTO THE MACHINE BEGIN TO COME APART. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529895 ↗
• MalfunctionJun 7, 2024Suction Problem; Suction Problem

  IT WAS REPORTED ON 10/05/2021 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9821 IS MALFUNCTIONING, "THREE SEPARATE KNEE SCOPES, SURGEON SAID THE AR-9821 SEEMED TO BE ASPIRATING TOO AGGRESSIVELY, ESSENTIALLY EMPTYING THE KNEE JOINT OF FLUID.". THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484987 ↗
• MalfunctionJun 5, 2024Peeled/Delaminated; Peeled/Delaminated

  ON 7/25/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-9821 APOLLORF ASPIRATING ABLATOR LINING THAT PROTECTS THE SHAFT OF THE DEVICE, IS WORN. THIS WAS DISCOVERED DURING A KNEE ARTHROSCOPY AND ACL PROCEDURE ON (B)(6) 2022. THE DEVICE DID NOT FAIL DURING THE PROCEDURE, HOWEVER, BECAUSE OF THE LINING BEING WORN OUT AND THE RISK OF LEAVING RESIDUE INSIDE THE PATIENT, ANOTHER ABLATOR WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470852 ↗
• MalfunctionJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-9821 APOLLORF BECAME LOOSE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2022 WHEN THE TIP BECAME LOOSE. IT REMAINED ATTACHED TO THE PROBE AND EVERYTHING WAS RECOVERED. ANOTHER APOLLO WAS OPENED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458514 ↗
• MalfunctionMay 8, 2024Excessive Heating; Excessive Heating

  ON 04/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9821 APOLLO IS RUNNING TOO HOT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO PATIENT HARM CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270293 ↗
• MalfunctionApr 19, 2024Overheating of Device; Overheating of Device

  ON 8/21/2024, ADDITIONAL INFORMATION WAS RECEIVED IN RESPONSE TO THE QUESTION: "WAS THE IRRIGATION PERFORMED THROUGH RF PROBE SUCTION? IF NOT, HOW WAS IT PERFORMED?" THE FACILITY ANSWERED: "YES, IRRIGATION AND SUCTION WERE CARRIED OUT AS USUAL. HOWEVER, THE USE OF IRRIGATION FLUID HEATED TO 35 DEGREES BY FACILITY AND MAY HAVE BEEN A CONTRIBUTING FACTOR."

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19144677 ↗
• MalfunctionFeb 6, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON 01/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9821 APOLLORF XL90S HEAD CAME OFF. THIS OCCURRED DURING USE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18654700 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY WHEN THE PAM WAS CONNECTED AND DISCONNECTED, THE DEVICE BROKE: ALL COMPONENTS WERE STRIPPED. THE DEVICE FELL APART OUTISDE OF THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 18140621 ↗
• MalfunctionOct 16, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE ABLATOR HAS TURNED BLACK AND A BLACK RUBBER RING HAS COME OFF IN THE PATIENT. EVERYTHING WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 17940347 ↗
• MalfunctionSep 15, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE BASE OF CONNECTOR SPLIT WHEN REMOVING. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 17758502 ↗
• MalfunctionSep 14, 2023Overheating of Device; Overheating of Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9821 APOLLORF XL90 WAND WAS CLOGGED AND THE METAL TIP/FACE BURNED. THIS OCCURRED DURING A SHOULDER SCOPE, WHERE THEY CLEANED THE FACE MULTIPLE TIMES WITH A SPINAL NEEDLE AND METAL SCRUB PAD BUT OPENED ANOTHER WAND TO COMPLETE THE CASE. THE PATIENT WAS NOT BURNED DURING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17746116 ↗
• MalfunctionSep 14, 2023Loose or Intermittent Connection; Material Separation; Loose or Intermittent Connection; Material Separation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE BASE WHERE THE DEVICE IS CONNECTED TO THE MACHINE CAME LOOSE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 17745354 ↗
• MalfunctionAug 31, 2023Flaked; Flaked

  ON 08/03/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-9821 APOLLORF XL90S BLACK COLORED COATING WAS FLAKING OFF THE SIDES OF THE PROBE. THIS OCCURRED DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2023, THERE WAS NO INJURY TO THE PATIENT HOWEVER THE DOCTOR SPENT AN EXTRA TWO MINUTES RETRIEVING THE PIECES OUT OF THE HIP JOINT AND FINISHED THE CASE WITH A AR-9821.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661128 ↗
• MalfunctionAug 30, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9821 APOLLO PROBE IS SHOWING AN ERROR MESSAGE, AND WIRES WERE EXPOSED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651250 ↗
• InjuryJul 19, 2023Output Problem; Output Problem

  ON 06/21/2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-9821 ABLATOR AND AR-9845 ABLATOR, AND AR-9800 CONSOLE ARE SHOWING ERROR 36 "OUTPUT FAILURE". THIS WAS DISCOVERED DURING A CASE, SURGEON NEEDED TO CREATE A LARGER INCISION TO FINISH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352320 ↗
• InjuryMay 15, 2023Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-9821, APOLLORF¿ XL90, ASPIRATING ABLATOR 90° BURNS TELESCOPE. THIS OCCURRED DURING SHOULDER ARTHROSCOPY ON (B)(6) 2023. PROCEDURE WAS CONVERTED TO OPEN ONE AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929417 ↗
• InjuryMay 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SURGERY THE METAL COAGULATION TIP DETACHED FROM THE DEVICE WHILE INSERTION. THE TIP GOT STUCK IN THE MUSCLE AND IT WAS IMPOSSIBLE TO RETRIEVE THE PIECE OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED WITH A NEW DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906737 ↗