Arthrex® AR-6420Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867039155), received between Apr 24, 2025 and Sep 17, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (5 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Increase in Suction

  It was reported that during a knee arthroscopy in the middle of the application it was noticed, that the pump on the inflow side rotated extremely quickly and the bags emptied extremely quickly. At first everything worked normally and all of a sudden, for no apparent reason, the pump created an extreme vacuum. The surgical assistant then inspected the tubings and finally decided to take one of the used pumps that was still on site. When the Arthrex representative inspected the pump afterwards, the tubing was installed incorrectly, but it was unclear whether this did not happen at the moment when the surgical assistant inspected the tubing, as the assistant had also touched the inflow side, according to their own information. The device was tested afterwards and everything worked perfectly. The patient had severe swelling after the surgery. The surgery was finished successfully with a new device with the same part number. It was not necessary to switch the surgical technique or do a second surgery.Update 08-Sep-2026.A user report was provided on the (b)(6) 2026 stating that there was a dysfunctional arthropump apparatus with overpressure. Change of tubing. Turn off and re-ignite. At

  Patient problems: Compartment syndrome

  MAUDE report 50803611 ↗
• InjuryAug 18, 2026Excess Flow or Over-Infusion

  It was reported that during an anterior cruciate ligament surgery the pump infused an unusually large amount of fluid into the knee at a very high rate. As a result, the pump operated irregularly, which caused the tubing to be pushed forward. The surgery was finished successfully with new tubing sets (AR-6420 & AR-6425). It was not necessary to switch the surgical technique or do a second surgery.***Update 12-Aug-2026:Further information was received on (b)(6) 2026 that no compartment syndrome occurred. The excess fluid was removed by irrigation (rinse), manual expression of fluid from the knee, and the use of a suction tube.

  Patient problems: Extravasation

  MAUDE report 50306179 ↗
• MalfunctionApr 23, 2026Increase in Pressure

  IT WAS REPORTED THAT DURING A SURGERY THE PRESSURE INSIDE THE PATIENT INCREASED. IT WAS FURTHER CONFIRMED BY THE CUSTOMER THAT THE ISSUE IS RELATED TO THE TUBING'S AND NOT THE PUMP AS THE DEVICE WORKED WITHOUT ISSUES WITH DIFFERENT TUBING SETS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. IT WAS FURTHER CONFIRMED THAT THE SPECIFIC DATE WHEN THE ISSUE OCURRED CANNOT BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965496 ↗
• MalfunctionApr 23, 2026Increase in Pressure

  IT WAS REPORTED THAT DURING A SURGERY THE PRESSURE INSIDE THE PATIENT INCREASED. IT WAS FURTHER CONFIRMED BY THE CUSTOMER THAT THE ISSUE IS RELATED TO THE TUBING'S AND NOT THE PUMP AS THE DEVICE WORKED WITHOUT ISSUES WITH DIFFERENT TUBING SETS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. IT WAS FURTHER CONFIRMED THAT THE SPECIFIC DATE WHEN THE ISSUE OCCURRED CANNOT BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965387 ↗
• MalfunctionApr 23, 2026Increase in Pressure

  IT WAS REPORTED THAT DURING A SURGERY THE PRESSURE INSIDE THE PATIENT INCREASED WHICH RESULTED IN FLUID SPRAYING OUT OF THE INCISION. IT WAS FURTHER CONFIRMED BY THE CUSTOMER THAT THE ISSUE IS RELATED TO THE TUBING'S AND NOT THE PUMP AS THE DEVICE WORKED WITHOUT ISSUES WITH DIFFERENT TUBING SETS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965302 ↗
• MalfunctionDec 3, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE FLOW RATE OF THE PUMP WAS TOO HIGH AND DID NOT GO DOWN. PER COMPLAINT REPORTER, THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704026 ↗
• MalfunctionOct 23, 2025Increase in Pressure; No Pressure; Increase in Pressure; No Pressure

  IT WAS REPORTED THAT DURING A SURGERY PRESSURE WAS NOT DETECTED, THEREFORE THE DEVICES SENT WATER CONTINUOUSLY RESULTING IN INTRAMUSCULAR SERUM LEAKAGE. THE ARTHROPUMP WAS SHUT DOWN DURING SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372236 ↗
• InjuryJun 19, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, AN ERROR MESSAGE APPEARED WITH THE DUAL CONSOLE. TOO MUCH FLUID ENTERED THE PATIENT/SHOULDER TOO QUICKLY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESFULLY BY CHANGING TO AN OPEN PROCEDURE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Swelling/ Edema

  MAUDE report 22292317 ↗
• MalfunctionMay 23, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY AFTER CONNECTING THE PUMP, IT DID NOT MAINTAIN PRESSURE. AFTER REPLACING THE SET EVERYTHING WAS FINE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080360 ↗
• 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 21902398 ↗