Arthrex® AR-3210-0051Recalls & reported problems
Arthrex, Inc. · NanoNeedle High Flow Operative Kit 125mm · 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 00888867419230), received between Mar 13, 2024 and Mar 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow 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
- Infusion or Flow 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.
MalfunctionMar 13, 2024Infusion or Flow Problem; Infusion or Flow Problem
ON 2/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3210-0051 NANONEEDLE HIGH FLOW OPERATIVE FACILITY HAD THE PUMP IN USE FOR INFLOW ONLY. THEY WERE ALSO USING A HIGH FLOW NANONEEDLE AND NANOSCOPE DURING THE PROCEDURE. THEY ENCOUNTERED AN ISSUE WITH THE INFLOW GOING UP TO 40 AND THEN DROPPING IMMEDIATELY. THIS WAS DISCOVERED DURING A PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT HARM. TECH SUPPORT TRIED TROUBLESHOOTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18896901 ↗
Other Accessories, arthroscopic devices
- Arthrex® AR-12990Arthrex, Inc. · Accessories, arthroscopic409 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page