Arthrex® AR-6413Recalls & reported problems
Arthrex, Inc. · Tube Set, Inflow, Arthroscopy · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867311329), received between Jan 11, 2024 and May 24, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Increase in Pressure” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Increase in Pressure1
- Pressure Problem1
Patient problems
- Insufficient Information1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2024Increase in Pressure; Increase in Pressure
ON 4/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) AND (B)(4) THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMP WAS INCORRECTLY READING THE PRESSURE AND CAUSING TOO MUCH FLUID TO BE PUMPED. THIS CAUSED THE PATIENT'S LEG TO SWELL VERY FAST. AND THE AR-6413 TUBE SET WAS THEN "RUINED" AFTER THE EVENT. THE PROCEDURE HAD TO BE STOPPED TO GET THE SWELLING UNDER CONTROL. THIS WAS DISCOVERED DURING A PROCEDURE.
Patient problems: Swelling/ Edema
MAUDE report 19394889 ↗MalfunctionJan 11, 2024Pressure Problem; Pressure Problem
ON 12/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6413 ARTHROSCOPY TUBE SET WAS OVER-PRESSURED WHEN THE FLUID WAS DISCHARGED AND THEN IT WAS TURNED OFF. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18492121 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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