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Arthrex® AR-3372-2402Recalls & reported problems

Arthrex, Inc. · SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867198470), received between Jun 12, 2024 and Feb 23, 2026 — classified as 3 malfunctions.

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Air/Gas in Device1
  • Material Twisted/Bent1
  • Physical Resistance/Sticking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 23, 2026Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING A HAND SURGERY THE TUBE GOT STUCK IN THE HAND WHEN PULLING IT OUT AND HAD TO BE REMOVED SEPARATELY. THE SURGERY WAS ALREADY COMPLETE AT THIS POINT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24412893 ↗
  • MalfunctionAug 8, 2024Air/Gas in Device; Air/Gas in Device

    ON 07/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(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 A

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19937943 ↗
  • MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent

    ON 05/16/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06570438 THAT AN AR-3372-2402 SHEATH WAS BENT DURING A PROCEDURE. ANOTHER SHEATH WAS USED TO COMPLETE THE CASE. CASE/PATIENT INVOLVEMENT NOT INDICATED.

    Patient problems: Insufficient Information

    MAUDE report 19524682 ↗

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Sources and updates

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