Arthrex® AR-6421Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867118058), received between Aug 7, 2020 and Sep 12, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Increase in Pressure; Increase in Pressure

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6480 DUALWAVE¿ ARTHROSCOPY FLUID MANAGEMENT SYSTEM WAS PUMPING TOO FAST. AT THE BEGINNING OF THE PROCEDURE, AN AR-6411 REDEUCE PUMP TUBING W/CONNECTOR, 8'' LONG WAS PRIMED, AND UPON INSERTING IT INTO THE JOINT, THE PUMP STARTED PUMPING TOO FAST, AND THE PATIENT'S KNEE STARTED TO FLARE UP. THE TUBING WAS PULLED OUT AND THE PUMP PRESSURE WAS LOWERED, AND IT SEEMED TO RETURN BACK TO NORMAL. THE PATIENT WAS SENT TO THE EMERGENCY ROOM. THE PUMP SETTINGS WERE SET TO 50, BUT IT STARTED TO SPIN VERY FAST AT THE START. THE PUMP WAS USED ALL DAY AND HAD NO ISSUES UNTIL THIS EVENT OCCURRED. THIS WAS DISCOVERED DURING THE CASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 20-AUG-2025. ON 09/04/25, ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM THE SALES REPRESENTATIVE INDICATING THAT THE PATIENT WAS SENT TO THE EMERGENCY ROOM AS THE HEALTHCARE PROVIDER BELIEVED THAT THE PATIENT HAD EXTRAVASATION FROM THE PUMP OVERPRESSURING DURING THE SURGERY THAT TOOK PLACE ON (B)(6) 2025. IT WAS NOTED THAT A PULSE WAS NOT FELT IN THE OPERATIVE KNEE, AND IT APPEARED PALE. BEFORE LEAVING THE OPERATING ROOM AND GOING TO THE EMER

  Patient problems: Extravasation

  MAUDE report 23037138 ↗
• MalfunctionSep 27, 2024Pressure Problem; Pressure Problem

  ON 09/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6480 DUALWAVE¿ ARTHROSCOPY FLUID MANAGEMENT SYSTEM HAS AN UNSTABLE PRESSURE CHANGE. THERE WAS NO PATIENT INJURY DURING THE CASE. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 09/17/2024, ADDITIONAL INFORMATION WAS PROVIDED, WHERE IT WAS REPORTED THAT THIS EVENT OCCURRED IN JUNE DURING AN UNKNOWN PROCEDURE WHERE AN AR-6411 AND AN AR-6421 ARTHREX TUBING WERE USED WITH THE PUMP. THE PUMP SETTINGS AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320684 ↗
• MalfunctionApr 25, 2024Increase in Pressure; Increase in Pressure

  ON 04/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMP HAD AN ISSUE. THE PRESSURE WAS MISREAD, AND TOO MUCH FLUID WAS DELIVERED. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 04/26/2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A KNEE ARTHROSCOPY PROCEDURE, ARTHREX TUBING WAS USED WITH THE PUMP, NO EXTRAVASATION OCCURRED AND THE COMPLAINT PUMP WAS USED TO COMPLETE THE PROCEDURE. THE SALES REPRESENTATIVE ALSO STATED THAT DAY OVER THE PHONE THAT BOTH TUBING SYSTEMS WERE DISCARDED BY THE FACILITY AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181251 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THAT TOOK PLACE (B)(6) 2020, THE PATIENT DEVELOPED COMPARTMENT SYNDROME. THE SURGEON NOTICED THE ISSUE WHEN PUTTING THE DRESSINGS ON THE PATIENT WHILE STILL IN THE PROCEDURE ROOM. THE SURGEON USED GRAVITY AND MASSAGE IN ATTEMPTS TO REMOVE THE FLUID BUT THEN HAD TO PERFORM A FASCIOTOMY. THIS WAS DONE WHILE STILL IN THE PROCEDURE ROOM, IMMEDIATELY AFTER THE ACL RECONSTRUCTION HAD BEEN COMPLETED. THE PATIENT HAD NOT YET LEFT THE ROOM. THE PATIENT WAS KEPT OVERNIGHT DUE TO THE ISSUE. THE WOUNDS WERE CLOSED ON (B)(6) 2020 AND THE PATIENT IS SCHEDULED TO BE DISCHARGED ON (B)(6) 2020. THE PUMP DID NOT ALARM DURING USE AND SEEMED TO PERFORM NORMALLY. THE SURGEON REQUESTED THE PRESSURE BE INCREASED SEVERAL TIMES DURING THE PROCEDURE. THE PRESSURE STARTED AT 35 AND ENDED AT 60. THERE WAS NO FLUID COMING OUT OF THE PORTALS. THE FOLLOWING TUBINGS WERE USED WITH THE PUMP: AR-6411 (LOT 40060968) AND AR-6421 (LOT 40067186).

  Patient problems: No Code Available

  MAUDE report 10379302 ↗