Arthrex® AR-6411Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867118027), received between Aug 7, 2020 and Sep 29, 2026 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934141 ↗
• MalfunctionNov 26, 2025Pressure Problem; Pressure Problem

  ON 11/06/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-6480 DW ARTHROSCOPY PUMP WAS READING A PRESSURE FAULT A FEW MINUTES INTO CASES. THIS HAS HAPPENED REPEATEDLY WITH DIFFERENT LOTS OF TUBING ON DIFFERENT DAYS. THE PUMP WAS SWAPPED OUT FOR ANOTHER UNIT WITH FRESH TUBING TO COMPLETE THESE CASES. THE DELAY WAS LESS THAN 5 MINUTES, AND NO HARM CAME TO THE PATIENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 11/12/25: THE REP ADVISED THAT AR-6411 AND AR-6412 TUBING WERE USED WITH THE PUMP, WITH MULTIPLE LOTS ATTEMPTED THAT WORKED ON DIFFERENT PUMPS. THE LOTS WERE NOT RECORDED. THE EVENT OCCURRED DURING A KNEE SCOPE. THE SETTINGS WERE PRESSURE 40, INFLOW ONLY. THE COMPLAINT PUMP WAS NOT USED TO COMPLETE THE PROCEDURE BECAUSE IT WOULD PRESSURE FAULT AND NOT RUN. IT WAS SWAPPED OUT FOR ANOTHER ARTHREX PUMP WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659206 ↗
• MalfunctionOct 31, 2025Material Deformation; Material Deformation

  ON 10/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-6411 REDEUCE PUMP TUBING W/CONN PRESSURE READER WITHIN THE RESERVOIR, EITHER WAS COMPLETELY FLAT OR HALF FLAT, WHICH CAUSED THE PUMP TO NOT RUN CORRECTLY. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439681 ↗
• MalfunctionOct 31, 2025Material Deformation; Material Deformation

  ON 10/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-6411 REDEUCE PUMP TUBING W/CONN PRESSURE READER WITHIN THE RESERVOIR, EITHER WAS COMPLETELY FLAT OR HALF FLAT, WHICH CAUSED THE PUMP TO NOT RUN CORRECTLY. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439413 ↗
• MalfunctionOct 29, 2025Material Deformation; Material Deformation

  ON 10/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-6411 REDEUCE PUMP TUBING W/ CONN PRESSURE READERS WITHIN THE RESERVOIR WAS COMPLETELY FLAT OR HALF FLAT, WHICH CAUSED THE PUMP TO NOT RUN CORRECTLY. THIS WAS DISCOVERED DURING THE CASE. THE TUBING WAS WRAPPED UP AND HELD UP TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415894 ↗
• MalfunctionOct 29, 2025Material Deformation; Material Deformation

  ON 10/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-6411 REDEUCE PUMP TUBING W/ CONN PRESSURE READERS WITHIN THE RESERVOIR WAS COMPLETELY FLAT OR HALF FLAT, WHICH CAUSED THE PUMP TO NOT RUN CORRECTLY. THIS WAS DISCOVERED DURING THE CASE. THE TUBING WAS WRAPPED UP AND HELD UP TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415749 ↗
• InjurySep 12, 2025Increase in Pressure; Increase in Pressure

  ON 08/15/25, 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 REDUCE 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 EMERGENCY

  Patient problems: Extravasation

  MAUDE report 23037136 ↗
• MalfunctionAug 8, 2025Pressure Problem; Pressure Problem

  ON 07/21/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-6411 REDUCE PUMP TUBING W/CONNECTOR EXPERIENCED A PRESSURE MALFUNCTION. THIS OCCURRED DURING A SURGICAL CASE EVERYTHING WAS RUNNING SMOOTHLY UNTIL THE DUALWAVE SOUNDED LIKE IT HAD RUN OUT OF WATER. ALL LINES WERE STILL OPEN AND THE SALINE BAG WAS ONLY HAFLWAY DONE. UPON CLOSER INSPECTION THE PRESSURE SENSOR REGION OF THE TUBING HAD FILLED TO THE TOP WITH WATER AND IT GAVE A PRESSURE ERROR. REPLACING THE TUBING THE CASE CONTINUED WITHOUT ISSUES FOR THE REST OF THE DAY.

  Patient problems: Insufficient Information

  MAUDE report 22748552 ↗
• InjuryJul 25, 2025Increase in Pressure; Increase in Pressure

  ON 07/3/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6411 INFLATED UNINTENDED QUAD AND KNEE TISSUE DURING A PROCEDURE. PATIENT AFFECTED. ON (B)(6) 2025 ADDITIONAL INFORMATION WAS OBTAINED VIA (B)(4). WHEREAS THE SALES REPRESENTATIVE HAD NOTED IN THE ORIGINAL REPORT ON (B)(6) 2025 THAT THEY THOUGHT IT MIGHT BE THE PUMP, SO IT WAS SWITCHED OUT, AND THEY WERE ABLE TO CONTINUE WITH NO ISSUES WITH THE PUMP. PATIENT WAS AFFECTED. PER THE INITIAL REPORTER, EXTRAVASATION WAS NOTED DURING THE SURGERY, WHERE THE PATIENT LEG WAS NOT BENDING ANY MORE THAN 30 DEGREES AS OPPOSED TO THE NORMAL 90 DEGREES.

  Patient problems: Extravasation; Loss of Range of Motion

  MAUDE report 22611533 ↗
• MalfunctionOct 29, 2024Pressure Problem; Pressure Problem

  ON 10/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6480 PUMP HAS A PRESSURE CONTROL THAT IS NOT WORKING. THE CONTACT HAS TRIED TROUBLESHOOTING, BUT HAS DECLINED ADDITIONAL TROUBLESHOOTING STEPS AT THIS TIME AND HAS REQUESTED FOR A REPLACEMENT TO BE SENT OUT. THIS OCCURRED DURING USE IN SEVERAL CASES WITH NO PATIENT EFFECT.

  Patient problems: Insufficient Information

  MAUDE report 20556073 ↗
• MalfunctionOct 24, 2024Pressure Problem; Pressure Problem

  ON 09/25/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6411 REDUCE PUMP TUBING BROKE DURING USE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. WHEN SURGEON USED SHAVER, THE PUMP ACTIVATED SHAVER BOOST AND WAS RUNNING 1200 ML/MIN. NURSE REPLACED PUMP TUBING AND ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529406 ↗
• MalfunctionSep 27, 2024Pressure Problem; Pressure Problem

  ON (B)(6) 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 (B)(6) 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 20320721 ↗
• MalfunctionSep 3, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ON 08/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6480 DUALWAVE PUMP WAS ACTING UP AND PUSHING A TON OF FLUID INTO THE PATIENT'S JOINT SPACE. THIS OCCURRED DURING A KNEE ARTHROSCOPY. THE PUMP FINALLY EVENED OUT AND WORKED AS USUAL. THE FLUID WAS MORE THAN USUAL IN THE KNEE POST-OP. ADDITIONAL INFORMATION WAS PROVIDED ON 08/13/2024, WHERE IT WAS STATED BY THE SALES REPRESENTATIVE THAT THIS EVENT OCCURRED ON 08/07/2024, AND AN AR-6410 TUBING WAS USED. THE TUBING WAS REPLACED, AND THERE WERE NO FURTHER ISSUES. THE PATIENT DID HAVE FLUID IN THE KNEE, AND THEY JUST PUT DRESSINGS ON AND THE KNEE FLUID CAME DOWN. THE PATIENT WAS DISCHARGED THAT DAY.

  Patient problems: Extravasation

  MAUDE report 20124416 ↗
• MalfunctionMay 21, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED, THAT DURING PREP FOR A KNEE PROCEDURE WHEN THE SALES REP WAS PRIMING THE PUMP THE AR-6411, TUBING WHEEL WAS OVER PRESSURING. THE CASE WAS COMPLETED USING A DIFFERENT AR-6411.

  Patient problems: Insufficient Information

  MAUDE report 19358693 ↗
• MalfunctionApr 16, 2024Pressure Problem; Pressure Problem

  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 19119108 ↗
• MalfunctionOct 3, 2023Insufficient Flow or Under Infusion; Improper Flow or Infusion; Insufficient Flow or Under Infusion; Improper Flow or Infusion

  ON 9/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06021994 THAT AN AR-6480 DW ARTHROSCOPY FLUID MANAGEMENT DEVICE HAD AN ISSUE. THE SURGEON NOTICED THE PUMP'S OUTFLOW WAS SLOW TO RESPOND, NOT PULLING FLUID FAST ENOUGH. THE PATIENT WAS NOT AFFECTED. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/7/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL AND PHONE: THIS OCCURRED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023. AN AR-6411 REDEUCE PUMP TUBING AND AR-6435 DUALWAVE OUTFLOW TUBE SET WITH REDEUCE TUBING SYSTEM WITH UNKNOWN LOT NUMBERS WERE USED. THE PUMP SETTINGS WERE AT 45MMHG, AND THE PUMP WAS NOT KEEPING UP WITH THE PRESSURE. SLIGHT EXTRAVASATION OCCURRED, IT WAS LOCALIZED AND A MANAGEABLE ISSUE. THEY USED A RINSE FUNCTION W/ CLOSED INFLOW PORTAL TO REMOVE THE EXCESS FLUID. THE PUMP WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE AND IS FINE TO DATE, THERE WAS NO HARM REPORTED AND NO CASE DELAY. THE TUBING SETS WERE DISCARDED AFTER THE PROCEDURE.

  Patient problems: Extravasation

  MAUDE report 17862873 ↗
• MalfunctionAug 30, 2023Pressure Problem; Pressure Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6411 REDUCE PUMP TUBING W/CONNECTOR HAD AN ISSUE WITH THE PRESSURE SENSOR. IT RUNS ON HIGH AND RUNNING OUT OF CONTROL. ANOTHER DEVICE WAS SWAPPED, AND THE SAME ISSUE OCCURRED. THE CASE WAS COMPLETED BY USING ANOTHER DEVICE WITH A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652378 ↗
• InjuryAug 10, 2021Excess Flow or Over-Infusion

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6411 REDUCE PUMP TUBING W/CONN, 8' LONG WAS NOT REGISTERING PROPERLY, CAUSING TOO MUCH FLUID TO GO INTO THE JOINT. THIS WAS DISCOVERED DURING USE IN KNEE ARTHROSCOPY ON (B)(6) 2021. THE CASE WAS COMPLETED USING THE SAME AR-6411. ICE WAS PLACED ON PATIENT POST- OP TO HELP WITH FLUID BUILD UP AND SWELLING WENT DOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 12300915 ↗
• InjuryAug 7, 2020Defective Device

  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: Pain; Swelling; Vascular System (Circulation), Impaired

  MAUDE report 10379287 ↗