Arthrex® AR-9831Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00888867428492), received between Oct 20, 2023 and Sep 24, 2026 — classified as 102 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882166 ↗
• MalfunctionAug 26, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50450627 ↗
• MalfunctionAug 11, 2026Material Fragmentation; Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212279 ↗
• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211471 ↗
• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211100 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50055729 ↗
• MalfunctionMay 6, 2026Overheating of Device

  IT WAS REPORTED THAT DURING THE SHOULDER ARTHROSCOPY, THE DEVICE ACTIVATED ON ITS OWN AND BEGAN TO COAGULATE. AS A RESULT, THE DEVICE OVERHEATED AND THE TIP TURNED RED. IN ADDITION, THE DEVICE BEGAN TO SMOKE. SINCE THE DEVICE WAS INSIDE THE PATIENT¿S ARTHROSCOPY PORTAL AT THE TIME OF THE INCIDENT, THE TISSUE WAS SUPERFICIALLY BURNED; HOWEVER, THIS WAS REMOVED DURING WOUND CLOSURE. NO FOOT SWITCH WAS USED TO OPERATE THE DEVICE. 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: Superficial (First Degree) Burn

  MAUDE report 25100915 ↗
• MalfunctionApr 27, 2026Flaked

  ON 7-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9831 APOLLO WAND'S INSULATION ON THE SHAFT IS FLAKING OFF DURING USE. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000469 ↗
• MalfunctionApr 14, 2026Material Separation

  ON 24-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9831 RF PROBE'S PLASTIC SLEEVE PEELED OFF INSIDE A PATIENT'S SHOULDER DURING A CASE. RIBBON WAS REMOVED FROM THE PATIENT'S SHOULDER WITH NO OTHER EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872106 ↗
• MalfunctionMar 17, 2026Material Split, Cut or Torn

  ON 24-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9831 RF WAND HAD A PIECE FOR THE BLACK SHEATH COVERING THE SHAFT OF THE WAND TEAR AWAY. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618459 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component

  ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9831 RF PROBE HAD A PIECE OF THE BLACK SHEATH FALL OFF. PIECE WAS RETRIEVED FROM THE JOINT WITH SHAVER. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594080 ↗
• MalfunctionFeb 24, 2026Temperature Problem; Suction Failure

  ON (B)(6) 2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT THE AR-9831 ASPIRATING ABLATOR PROBE SUCTION WAS NOT WORKING, AND THE REFLUX TEMPERATURE WAS HIGH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER PRODUCT OF THE SAME TYPE, AND NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431523 ↗
• MalfunctionFeb 4, 2026Overheating of Device

  ON 14-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9831 RF PROBE BURNED A PATIENT. NOTICED DURING A CASE. ADDITIONAL INFORMATION PROVIDED 20-JAN-2026: PER THE REP, THE WAND WAS BEING RUN WITH SALINE WHEN THE BURN OCCURRED ON ONE SIDE OF THE INCISION SITE. THE BURN WAS NOTED TO BE A SUPERFICIAL BURN AND WAS TREATED WITH ADAPTIC DRESSING. FOLLOW-UP WITH THE PATIENT TO DETERMINE CURRENT CONDITION OF THE PATIENT AND BURN WAS ATTEMPTED, BUT NO INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION PROVIDED 22-JAN-2026: PER THE REP, THIS EVENT OCCURRED DURING A SHOULDER CASE WHILE THE WAND WAS BEING USED IN THE PATIENT BODY. DEFAULT SETTINGS ON THE CONSOLE WERE USED, A SUCTION ADAPTER WAS USED ON AN EXTERNAL SUCTION SOURCE, AND PROLONGED ABLATION WAS NOT USED. NO PHOTOS OF THE BURN ARE AVAILABLE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24257949 ↗
• MalfunctionFeb 3, 2026Material Frayed

  ON 20-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9831 APOLLO RF I90 ASPIRATING ABLATOR HAD THE BLACK INSULATION ON THE DISTAL END OF THE ABLATOR HAD FRAYED OFF. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE. NOTHING BROKE INSIDE THE PATIENT, AND THE PATIENT WAS NOT AFFECTED. A NEW PART OF THE SAME LOT WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248937 ↗
• 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 23741602 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 10/20/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-9831 ABLATOR ELECTRODE CAME OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. A NEW PRODUCT WAS OPENED, AND THE SURGERY WAS COMPLETED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391549 ↗
• MalfunctionAug 12, 2025Break; Break

  ON 07/28/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-9831 PROBE ELECTRODE FELL OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782802 ↗
• MalfunctionJul 18, 2025Overheating of Device; Overheating of Device

  ON 06/25/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9831 ASPIRATING ABLATOR PROBE STARTED OVERHEATING AND RANDOMLY AND SPORADICALLY CHANGING THE ABLATION INTENSITY. THE CASE WAS FINISHED SUCCESSFULLY. THIS OCCURRED DURING A ROTATOR CUFF REPAIR WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542423 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING THE TREATMENT FOR A SUBACROMIAL IMPINGEMENT SYNDROME THE TIP OF THE DEVICE BROKE OFF INSIDE THE SHOULDER. THE BROKEN PART WAS REMOVED OUT OF THE PATIENT. 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 22509375 ↗
• MalfunctionJun 23, 2025Peeled/Delaminated; Use of Device Problem; Peeled/Delaminated; Use of Device Problem

  ON 05/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9831 ABLATION PROBE'S PLASTIC WAS COMPROMISED DURING USE. ISSUE NOTICED DURING CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306544 ↗
• MalfunctionJun 19, 2025Use of Device Problem; Use of Device Problem

  ON 05/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9831 ABLATION PROBE'S PLASTIC WAS COMPROMISED DURING USE. ISSUE NOTICED DURING CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292709 ↗
• MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY A PART OF THE TIP STARTED TO COME OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 22078720 ↗
• MalfunctionMay 22, 2025Overheating of Device; Overheating of Device

  ON 05/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9831 APOLLO RF I90 ASPIRATING ABLATOR STRUGGLED TO ABLATE AT PRESET SETTING. UPON INCREASING IN ABLATION SETTING, SHAFT TEMPERATURE INCREASED AND WAS HOT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073185 ↗
• MalfunctionMay 19, 2025Break; Break

  ON 04/29/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9831 APOLLO ASPIRATING ABLATOR HAD A CHIPPED PIECE OF PLASTIC ON THE DEVICE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043246 ↗
• MalfunctionMay 6, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE TIP OF THE APOLLO HEATED AND BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 21968047 ↗