Arthrex® AR-3370-0002Recalls & reported problems
Arthrex, Inc. · STOPCOCK,DOUBLE,SPARE,FOR SYNERGY SHEATH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867029897), received between May 25, 2024 and Dec 27, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
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
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2024Break; Break
ON 12/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3370-0002 STOPCOCK HAS A VALVE THAT BROKE OFF OF THE SHEATH AT THE HUB. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21027883 ↗MalfunctionOct 4, 2024Break; Break
ON 09/20/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06668583 THAT AN AR-3370-0002 STOPCOCK, DOUBLE, SPARE, FOR SYNERGY HD3 SHEATH LEVER BROKE OFF DURING A CASE. THERE WAS NO HARM TO THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20367621 ↗MalfunctionJun 4, 2024Break; Break
IT WAS REPORTED ON 11/10/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3370-0002 STOPCOCK INFLOW PORTION BROKE OFF DURING CASE. CASE INVOLVEMENT, NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19459427 ↗MalfunctionMay 25, 2024Break; Break
IT WAS REPORTED THAT ONE OF THE VALVES HAS FALLEN OFF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19398189 ↗
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.
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