Arthrex® AR-6412Recalls & reported problems
Arthrex, Inc. · GRAVITY TUBING · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867295582), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Pressure Problem” (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
- Pressure Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2025Pressure Problem; Pressure Problem
ON 11/06/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-6480 DW ARTHROSCOPY PUMP WAS READING A PRESSURE FAULT A FEW MINUTES INTO CASES. THIS HAS HAPPENED REPEATEDLY WITH DIFFERENT LOTS OF TUBING ON DIFFERENT DAYS. THE PUMP WAS SWAPPED OUT FOR ANOTHER UNIT WITH FRESH TUBING TO COMPLETE THESE CASES. THE DELAY WAS LESS THAN 5 MINUTES, AND NO HARM CAME TO THE PATIENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 11/12/25: THE REP ADVISED THAT AR-6411 AND AR-6412 TUBING WERE USED WITH THE PUMP, WITH MULTIPLE LOTS ATTEMPTED THAT WORKED ON DIFFERENT PUMPS. THE LOTS WERE NOT RECORDED. THE EVENT OCCURRED DURING A KNEE SCOPE. THE SETTINGS WERE PRESSURE 40, INFLOW ONLY. THE COMPLAINT PUMP WAS NOT USED TO COMPLETE THE PROCEDURE BECAUSE IT WOULD PRESSURE FAULT AND NOT RUN. IT WAS SWAPPED OUT FOR ANOTHER ARTHREX PUMP WITH NO ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659061 ↗
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- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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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