Arthrex® AR-6425Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867039315), received between Apr 24, 2025 and Sep 9, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 9, 2026Pressure Problem

  It was reported that the during a rotator cuff surgery device pumps too much liquid. There was no harm for patient, operator or third party reported. The surgery was finished successfully with the the same pump. Update (b)(6) 2026:Further information has been provided that the surgery was continued with the same tubing and same pump. Aclamp/pressure test has been performed prior to tubing use. The neoprene sleeve did not flatten/compress.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689807 ↗
• InjuryDec 12, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING LATERAL CLAVICULAR RESECTION AN ERROR MESSAGE "PRESSURE FALL" WAS RECEIVED AND THE PATIENT'S SHOULDER JOINT IS BECAME FULL OF WATER (THE SURGEON WAS NOT ABLE TO SEES ANYTHING IN THE JOINT). THE SUCTION THROUGH THE SHAVER DOES NOT EXTRACT FLUID, WHICH MEANS THAT WATER ONLY GOES INTO THE SHOULDER AND NOT OUT AGAIN. THE STAFF TRIED TO RESOLVE THE PROBLEM, BUT WAS UNSUCCESSFUL. THE SHOULDER BECAME VERY SWOLLEN BECAUSE OF THIS ISSUE AND THIS PART OF THE PROCEDURE WAS TERMINATED. THE REMAINING PART OF THE PROCEDURE (LATERAL CLAVICULAR RESECTION) WAS PERFORMED AS AN OPEN PROCEDURE AND WAS COMPLETED AS PLANNED. ***UPDATE DW 10-DEC-2025: FURTHER INFORMATION WAS PROVIDED THAT AN AR-6420, AR-6425 AND AN AR-6430 TUBING WAS USED DURING THE PROCEDURE BUT THEN DISCARDED. IT WAS FURTHER REPORTED THAT NO ADDITIONAL TREATMENT WAS PERFORMED.

  Patient problems: Swelling/ Edema

  MAUDE report 23792527 ↗
• InjuryApr 24, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE PUMP AR-6480 (SN: (B)(6) WAS USED WITH THE TUBINGS AR-6420 (LOT: Z4053) AND AR-6425 (LOT: X4080). A CLAMPING TEST CARRIED OUT AFTER FILLING THE TUBE SET. AFTER APPROX. 5 MINUTES WITHOUT ANY ABNORMALITIES IN THE PUMP, THE PUMP SUDDENLY PUMPED AT MAXIMUM FLOW RATE (1200 ML/MIN) AND THEN STOPPED WITH A WARNING. THE SURGICAL ASSISTANT RESTARTED THE PUMP, AND THE PUMP AGAIN PUMPED AT MAXIMUM FLOW RATE WITHOUT STOPPING.. THE TUBE WAS THEN UNHOOKED FROM THE PUMP, THE PRESSURE SENSOR WAS DISCONNECTED AND RECONNECTED, THE SAME TUBE WAS REINSERTED, AND THE PUMP WAS THEN RESTARTED.. THE SURGERY COULDN`T BE COMPLETED SUCCESSFULLY DUE TO A COMPARTMENT SYNDROME WITH SPLITTING OF THE LOWER LEG. A SECOND PROCEDURE IS/WAS REQUIRED. ***UPDATE AVOE 10-APR-2025 IT WAS FURTHER REPORTED THAT THE COMPARTMENT SYNDROME WAS CURRENTLY TREATED WITH RELIEF INCISIONS ON THE LOWER LEG. THE PATIENT IS CURRENTLY BEING TREATED AS AN INPATIENT AND THE SECOND OPERATION HAS NOT YET TAKEN PLACE.

  Patient problems: Compartment syndrome

  MAUDE report 21902393 ↗