Arthrex® AR-3373-4202Recalls & reported problems
Arthrex, Inc. · SHEATH,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867431270), received between Jan 28, 2025 and May 27, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Detachment of Device or Device Component2
- Device Damaged by Another Device1
- Material Frayed1
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Break
ON 28-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4202 SHEATH'S O-RING BROKE FREE AND WENT INTO THE PATIENT WITH WATER FLOW. NOTICED DURING A CASE AND COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301005 ↗MalfunctionMay 27, 2026Detachment of Device or Device Component
ON 28-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4202 SHEATH'S O-RING CAME OUT AND ENDED UP INSIDE THE PATIENT'S SHOULDER. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM REPORTED. THE O-RING WAS ABLE TO BE SUCCESSFULLY RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25300847 ↗MalfunctionMay 1, 2026Material Frayed
ON 6-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4202 SHEATH IS FRAYED AT THE DISTAL TIP. NOTICED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055627 ↗MalfunctionApr 30, 2026Break
ON 13-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4202 SHEATH IS DAMAGED, HAS A PIECE MISSING. NOTICED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25042804 ↗MalfunctionNov 24, 2025Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT DURING A SURGERY THE PATIENT EXPERIENCED AN INVOLUNTARY ARM MOVEMENT WHICH CAUSED THE ¿FISH EYE¿ END OF THE PANOSCOPE TO COME INTO CONTACT WITH THE SHEATH. THIS RESULTED IN DAMAGE TO BOTH THE SCOPE AND THE SHEATH. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631306 ↗MalfunctionJul 14, 2025Sharp Edges; Sharp Edges
ON 06/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-3373-4202 SHEATH IS SHARP AT THE TIP (FENESTRATED PART). WHEN GOING IN AND OUT OF THE PATIENT, IT IS CAUSING ADDITIONAL DAMAGE TO TISSUE AND CARTILAGE. DISCOVERED DURING A CASE AND DEVICE SWAPPED.
Patient problems: Insufficient Information
MAUDE report 22494282 ↗MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 01/02/2025 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4202 SHEATH STOPCOCK FELL OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21255814 ↗
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- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- 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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