Arthrex® AR-2386-11Recalls & reported problems
Arthrex, Inc. · QuadPro™ Harvester, 11 MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867344686), received between Jun 11, 2024 and Dec 2, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (3 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
- Naturally Worn3
- Defective Component1
- Failure to Cut1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Failure to Cut; Failure to Cut
ON 11/13/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2386-11 QUADPRO HARVESTER PLUNGER WOULD NOT CUT THE GRAFT. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23697251 ↗MalfunctionMay 23, 2025Naturally Worn; Naturally Worn
ON 05/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-2386-11 QUADPRO HARVESTERS WERE NOT AS SHARP AS THEY SHOULD BE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079970 ↗MalfunctionMay 23, 2025Naturally Worn; Naturally Worn
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06877394 THAT (QTY. 3) OF AN AR-2386-11 QUADPRO HARVESTERS WERE NOT AS SHARP AS THEY SHOULD BE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079817 ↗MalfunctionMay 23, 2025Naturally Worn; Naturally Worn
ON 05/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-2386-11 QUADPRO HARVESTERS WERE NOT AS SHARP AS THEY SHOULD BE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079727 ↗MalfunctionJun 11, 2024Defective Component; Defective Component
IT WAS REPORTED DURING AN ACL RECONSTRUCTION THE HARVESTER CUT THE GRAFT SHORT IN LENGTH AND SMALL IN DIAMETER. THE SURGEON USED AN ALLOGRAFT INSTEAD AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19513971 ↗
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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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