Arthrex® AR-6482Recalls & reported problems
Arthrex, Inc. · DW REMOTE · Class 2
Quick summary
This Arthrex DualWave remote control is a handheld corded controller used with the company's arthroscopy shaver equipment during shoulder and knee procedures. Most of the 49 reports describe the remote's cord or casing fraying, splitting apart, or separating where it joins the base, leaving electrical wires exposed during surgery; 47 reports are malfunctions, 2 involve injuries, and there are no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00888867039421), received between Dec 6, 2022 and Dec 12, 2025 — classified as 2 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (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.
Reports received per month
Most reported problems
Device problems
- Material Frayed10
- Material Deformation9
- Material Separation7
- Detachment of Device or Device Component5
- Electrical /Electronic Property Problem4
- Material Split, Cut or Torn4
- Key or Button Unresponsive/not Working3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information6
- Extravasation1
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Material Frayed; Material Frayed
ON 11/13/2025, A FACILITIES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-6482 DUALWAVE REMOTE HAS EXPOSED WIRES. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23790091 ↗MalfunctionDec 12, 2025Material Frayed; Material Frayed
ON 11/13/2025, A FACILITIES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-6482 DUALWAVE REMOTE HAS EXPOSED WIRES. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23790090 ↗MalfunctionJul 14, 2025Material Frayed; Material Frayed
ON (B)(6) 2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DW REMOTE HAS EXPOSED WIRES. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22493913 ↗MalfunctionJun 25, 2025Peeled/Delaminated; Peeled/Delaminated
ON 05/29/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06905110 THAT AN AR-6482 DW REMOTE HAS EXPOSED WIRES. THIS WAS CAUSED BY THE INSULATION PROTECTION, WHERE THE BASE MEETS THE REMOTE BECOMING SEPARATED THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22327575 ↗MalfunctionMar 6, 2025Material Frayed; Material Frayed
ON 02/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 REMOTE'S CORD IS FRAYED, EXPOSING WIRES. ISSUE DISCOVERED DURING SURGERY, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21535623 ↗MalfunctionOct 31, 2024Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 REMOTE HAS EXPOSED WIRES ON THE BACK OF IT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577392 ↗MalfunctionOct 29, 2024Material Deformation; Material Deformation
ON 10/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DUALWAVE REMOTE HAD EXPOSED WIRES. THIS WAS DISCOVERED DURING USE, AND WAS SWITCHED OUT TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 20557215 ↗MalfunctionOct 3, 2024Material Separation; Material Separation
ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DW REMOTE HAS AN EXPOSED WIRE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20358902 ↗MalfunctionOct 3, 2024Material Separation; Material Separation
ON 09/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DW REMOTE CONNECTION COATING RIPPED OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20358198 ↗MalfunctionSep 13, 2024Material Frayed; Material Frayed
ON 08/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DW REMOTE HAS CORDS SHOWING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20213443 ↗MalfunctionJul 5, 2024Material Frayed; Material Frayed
ON 6/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DW REMOTE CORD HAD EXPOSED WIRES. THE CASE WAS COMPLETED WITH ANOTHER AR-6482 DW REMOTE WITH NO ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19683874 ↗MalfunctionJul 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 06/06/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DW REMOTE CONTROL HAS EXPOSED CABLE WIRING. CASE/PATIENT INVOLVEMENT NOT INDICATED.
Patient problems: Insufficient Information
MAUDE report 19657577 ↗MalfunctionMay 8, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
ON 9/15/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THE FOLLOWING: AN AR-6482 REMOTE IS NOT RESPONDING WHEN PLUGGED IN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO CASE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266849 ↗MalfunctionApr 25, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
ON 9/15/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THE FOLLOWING: AN AR-6482 REMOTE IS NOT RESPONDING WHEN PLUGGED IN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO CASE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181335 ↗MalfunctionApr 24, 2024Electrical Power Problem; Electrical Power Problem
ON 9/15/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THE FOLLOWING: AN AR-6482 REMOTE IS NOT RESPONDING WHEN PLUGGED IN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO CASE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19171217 ↗MalfunctionApr 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS B)(4) THAT AN AR-6482 DW REMOTE WIRING CAME LOOSE AND NOT CONNECTING AS INTENDED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124138 ↗MalfunctionApr 10, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
ON 9/15/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THE FOLLOWING: AN AR-6482 REMOTE IS NOT RESPONDING WHEN PLUGGED IN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 19082204 ↗MalfunctionApr 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 03/19/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DW REMOTE HAD EXPOSED WIRES. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19061459 ↗MalfunctionMar 13, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
ON 02/29/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DW REMOTE CORD IS EXPOSED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18896870 ↗MalfunctionMar 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 02/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6482 DW REMOTE WAS DAMAGED, THE CORD WAS CUT. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18867888 ↗MalfunctionFeb 27, 2024Material Frayed; Material Frayed
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-6482 REMOTE HAS FRAYED WIRING. THIS WAS DISCOVERED DURING A PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW REMOTE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793711 ↗MalfunctionFeb 23, 2024Material Deformation; Material Deformation
ON 02/06/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06478064 THAT AN AR-6482 DUALWAVE REMOTES WIRES WERE SHOWING AT THE TOP. THIS WAS DISCOVERED DURING A PROCEDURE WHERE THEY PUT A COBAN OVER IT AND KEPT IT AWAY FROM LIQUIDS.
Patient problems: Insufficient Information
MAUDE report 18771333 ↗MalfunctionFeb 20, 2024Material Deformation; Material Deformation
ON 02/02/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A QTY. 2 OF AR-6482 DW REMOTES HAD EXPOSED REMOTE WIRES. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18742527 ↗MalfunctionFeb 20, 2024Material Deformation; Material Deformation
ON 02/02/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A QTY. 2 OF AR-6482 DW REMOTES HAD EXPOSED REMOTE WIRES. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18742418 ↗MalfunctionFeb 5, 2024Material Separation; Material Separation
ON 07/27/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-6482 REMOTE HAS EXPOSED WIRES DUE TO A MISSING PIECE. THIS OCCURRED DURING USE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18641508 ↗
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.