Arthrex® AR-3372-2401Recalls & reported problems
Arthrex, Inc. · SHEATH, 1 STOPCOCK FOR 2.4MM SCOPE · 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 00888867198463), received between Aug 8, 2024 and Aug 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (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
- Air/Gas in Device1
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.
MalfunctionAug 8, 2024Air/Gas in Device; Air/Gas in Device
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3372-2401 SHEATH OR AR-3372-2402 SHEATH IN COMBINATION WITH AR-3350-2430 ARTHROSCOPE, 30° RESULTS IN INADEQUATE FLUID FLOW THROUGH THE JOINT WHICH CAUSED AIR BUBBLES TO FORM. WHEN THIS HAPPENED, THEY NEEDED TO WAIT BEFORE RESUMING SURGERY. CASE COMPLETED WITHOUT HARM TO THE PATIENT. THERE WAS NO ISSUE WHEN AR-3350-2470 ARTHROSCOPE 70° WAS USED WITH THE SAME SHEATH. THE REP SUSPECTS THIS IS BECAUSE THE TIP OF THE 70-DEGREE SCOPE STICKS OUT OF THE END OF THE SHEATH SLIGHTLY. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/17/2024: THE SHEATH USED WITH THE 30-DEGREE SCOPE WAS THE SAME EXACT SHEATH USED WITH THE 70-DEGREE SCOPE. IT WAS USED IN THE SAME CASE BUT ONLY TESTED THE 70-DEGREE SCOPE AND WAS NOT USED IN THE JOINT. THE 30-DEGREE SCOPE WAS THE ONE USED FOR THE CASE, BUT IT WAS TESTED BOTH OUTSIDE OF THE JOINT TO SEE THE FLOW BETWEEN THE TWO. THE PUMP TUBING WAS PRIMED BEFORE THE START OF THE CASE. THIS OCCURRED DURING AN ANKLE SCOPE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/22/2024: THIS OCCURRED ON (B)(6) 2024 DURING AN ANKLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937951 ↗
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- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- 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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