Arthrex® AR-6430Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00888867039322), received between Mar 9, 2020 and Sep 17, 2026 — classified as 13 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (10 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 25 most recent of 46 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 8th of September 2026 stating that there was a dysfunctional arthropump apparatus with overpressure. Change of tubing. Turn off and re-

  Patient problems: Compartment syndrome

  MAUDE report 50803617 ↗
• MalfunctionSep 10, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713228 ↗
• MalfunctionAug 27, 2026Increase in Pressure

  On (b)(6) 2026, it was reported by a Sales Representative via (b)(4) that an AR-6430 cassette and tubing set elevated pressure towards the end of the case like it was not connected. This occurred during use in a knee scope case with no patient effect.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50480243 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak; Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50207930 ↗
• MalfunctionMar 20, 2026Suction Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE SUCTION OF THE DEVICE WAS DEFECT. 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. THIS LINE WAS CREATED FOR THE UNKNOWN TUBING THAT WAS USED WITH THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649527 ↗
• 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 BECOMING 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 23791666 ↗
• MalfunctionSep 16, 2025No Flow; No Flow

  ON 27TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-6480, DUALWAVE¿ ARTHROSCOPY FLUID MANAGEMENT SYSTEM, THE PUMP MALFUNCTIONED, THE OUTFLOW DID NOT FUNCTION WHEN THE SHAVER WAS ACTIVATED. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY ABORTED THE OUTFLOW TUBING USAGE. THEY CHANGED TO NORMAL TUBING TO PLUG INTO A COMPETITOR'S DEVICE. TROUBLESHOOTING WAS PERFORMED WITH THE I&R MANAGER THROUGH FACETIME AND THE CABLE WAS CHANGED, THE SHAVER PORT WAS CHANGED, BUT NOTHING WORKED. THE SHAVER THAT WAS CONNECTED TO THE PUMP WAS AR-8305, LOT : EAM160194. (ADDING COMPLAINT FROM ARTHREX TUBING AS INDICATED IN PRODUCT LINE CHECKLIST)

  Patient problems: Insufficient Information

  MAUDE report 23062351 ↗
• MalfunctionJul 25, 2025No Flow; Suction Failure; No Flow; Suction Failure

  ON 7TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-6430, DUALWAVE OUTFLOW TUBE SET, WHEN THE HOSPITAL TEAM ATTACHED THE SUCTION TUBING FROM THE OUTFLOW, THERE WAS NO SUCTION AT ALL WHEN THE SHAVER WAS ACTIVATED. THEY SWITCHED ON AND OFF THE MACHINE, DISCONNECTED AND RECONNECTED THE TUBING BUT THE PROBLEM STILL PERSISTED. THIS WAS DETECTED DURING A ROTATOR CUFF AND LABRAL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY ATTACHING TO EXTERNAL SUCTION INSTEAD. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609515 ↗
• 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 SUCCESSFULLY BY CHANGING TO AN OPEN PROCEDURE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Swelling/ Edema

  MAUDE report 22289300 ↗
• MalfunctionJan 13, 2025Suction Problem; Suction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6430 DUALWAVE OUTFLOW TUBE SET WAS DAMAGED. THERE WAS NO SUCTION. THIS WAS DISCOVERED DURING A CASE, WITH NO PATIENT EFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138420 ↗
• MalfunctionOct 3, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE NEW OUTFLOW TUBING CONNECTOR SEEMED TO SUCK LESS THAN THE PREVIOUS ONES AND CLOGGED UP MORE EASILY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358734 ↗
• MalfunctionSep 12, 2024Collapse; Collapse

  ON 08/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06642691 THAT AN AR-6430 DUALWAVE OUTFLOW TUBE SET COLLAPSED. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED. IT IS UNKNOWN IF AN ARTHREX PUMP WAS BEING USED AT THE TIME. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2024 WHERE IT WAS STATED THIS EVENT OCCURRED DURING A KNEE SCOPE/ACL WHEN THE OUTFLOW TUBING KINKED AT THE PUMP BOX. THEY WENT TO DIRECT SUCTION TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20199512 ↗
• MalfunctionSep 12, 2024Collapse; Collapse

  ON 08/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6430 DUALWAVE OUTFLOW TUBE SET COLLAPSED. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 20199490 ↗
• MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6430 DUALWAVE OUTFLOW TUBE SET COLLAPSED. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED. ADDITIONAL INFORMATION WAS PROVIDED ON 09/10/2024 WHERE IT WAS STATED THIS EVENT OCCURRED DURING A KNEE SCOPE/ACL WHEN THE OUTFLOW TUBING KINKED AT THE PUMP BOX. THEY WENT TO DIRECT SUCTION TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20192442 ↗
• MalfunctionSep 11, 2024Collapse; Collapse

  ADDITIONAL INFORMATION WAS PROVIDED 9/10/2024 WHERE THE SALES REPRESENTATIVE STATED THAT THE EVENT OCCURRED ON (B)(6) 2024. THE PROCEDURE WAS A KNEW SCOPE/ACL. NO PHOTOS WERE CAPTURED OF THE EVENT. ARTHREX REP WAS PRESENT DURING THE PROCEDURE. THE OUTFLOW TUBING KINKED AT THE PUMP BOX. DIRECT SUCTION WAS USED TO COMPLETE THE PROCEDURE WHICH RESULTED IN A 1-MINUTE DELAY. NO ADDITIONAL ANESTHESIA WAS REQUIRED AND NO PATIENT HARM. TUBING WAS RETURNED

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192330 ↗
• MalfunctionSep 11, 2024Collapse; Collapse

  ON 08/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6). THAT AN AR-6430 DUALWAVE OUTFLOW TUBE SET COLLAPSED. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 20191928 ↗
• MalfunctionJun 21, 2024Failure to Pump; Suction Failure; Failure to Pump; Suction Failure

  IT WAS REPORTED THAT THE PUMP IS DEFECTIVE. THIS WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. ALSO THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 12-JUN-2024 FURTHER INFORMATION WAS PROVIDED THAT THE ERROR OCCURRED DURING AN ARTHROSCOPY SURGERY ON THE (B)(6) 2024. DURING OPERATION THE SURGEON WAS NOT SATISFIED WITH THE SUCTION OF THE DEVICE. THE SUCTION TUBING WAS UNHOOKED AGAIN AND RE-HOOKED. UNFORTUNATELY WITHOUT SUCCESS. AS A RESULT OF ALL THIS, THE OTHER TUBING (INLET) NATURALLY BECAME UNSTERILE. THE PUMP WAS STOPPED AND THE OTHER TUBING WAS ALSO REPLACED. AFTER THIS, THE PUMP COULD NO LONGER BE STARTED (THE DEVICE WAS RUNNING BUT NO LONGER SHOWED ANY REACTION). A SECOND AS TOWER WAS USED AND THE SURGEON WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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. THE TUBINGS AR-6420, AR-6425 AND AR-6430 WITH UNKNOWN LOT NUMBERS WERE USED WITH THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586707 ↗
• InjuryJun 21, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT AN EXTERNAL MEDICAL TECHNICIAN CONSULTANT HAS FOUND A PROBLEM WITH INCREASING PRESSURE AND THE ERROR MESSAGE "PRESSURE TO HIGH" WAS DISPLAYED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED DURING THE TESTING OF THE EXTERNAL TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. UPDATE DW 27-MAY-2024: FURTHER INFORMATION WERE PROVIDED THAT THE ISSUE OCCURRED DURING AN ARTHROSCOPIC HIP SURGERY ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT THE SURGERY COULD BE FINISHED SUCCESSFULLY WITH A CHANGE OF THE PUMP AND TUBES. NO ADDITIONAL SURGERY IS PLANNED HOWEVER THE PATIENT EXPERIENCED SEVERE PAIN FOR A PERIOD OF THREE DAYS FOLLOWING HER SURGICAL PROCEDURE.

  Patient problems: Pain

  MAUDE report 19581730 ↗
• InjuryJun 21, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY A COMPARTMENT SYNDROME HAS OCCURRED. THE SURGERY BEGAN WITHOUT ISSUES UNTIL SUDDENLY WATER WAS PRESSED OUT OF THE SHAFT AND THE TAP DUE TO OVER-PRESSURE. IT WAS FURTHER REPORTED THAT THE CUSTOMER NOTICED THAT WATER FLEW OUT HOWEVER THE CUSTOMER CONTINUED THE SURGERY AND NO ALARM SOUND WAS NOTICED. THE LOWER LEG WAS INFLATED AND THE OUTFLOW CASSETTE BARELY PUMPED OUT AS THERE WAS HARDLY ANY FLUID IN THE WASTE CONTAINER. WHEN THE CUSTOMER NOTICED THE INFLATED LOWER LEG THE SURGERY WAS ABORTED AND THE LEG WAS OPENED TO REMOVE THE FLUID. UPDATE DW 29-MAY-2024: FURTHER INFORMATION WERE PROVIDED THAT DUE TO THE FAILURE THE PATIENT HAD TO BE KEPT OVERNIGHT AND ADDITIONAL SURGERIES WERE NECESSARY. IT WAS FURTHER REPORTED THAT THE PUMP OVER DELIVERED AND WAS NOISY. THE PUMP WAS USED WITH THE FOLLOWING TUBING AR-6420 BATCH Z3058, AR-6425 BATCH X3096, AR-6430 BATCH 310027.

  Patient problems: Extravasation

  MAUDE report 19580136 ↗
• MalfunctionJun 15, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPY PROCEDURE THE AR-6430, TUBING WOULD NOT ALLOW SUCTION TO FLOW THRU RED TUBING. THE TUBING WAS INSERTED AND BOTH INDICATORS ON THE PUMP WERE VERIFIED THE AR-6430, WAS HOOKED UP CORRECTLY. ONCE WE CLOSED THE BLACK HANDLE ON THE PUMP THE SUCTION WOULD STOP, ONCE WE OPENED THE BLACK HANDLE SUCTION WOULD PASS THROUGH. THE CASE WAS COMPLETED USING AR-6410, MAIN PUMP TUBING ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543692 ↗
• MalfunctionJun 5, 2024Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY IT WAS NOTICED THAT THE DEVICE IS DEFECTIVE. THERE IS A MALFUNCTION OF THE SUCTION AND BLOCKING OF THE WATER OUTLET RED TUBING. 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 19472700 ↗
• MalfunctionJun 5, 2024Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY NO ASPIRATION WITH THIS TUBING COULD BE ACHIEVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19472148 ↗
• MalfunctionJun 3, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THERE WAS NO SUCTION FROM THE DEVICE. THE DEVICE WOULD NOT SUCK FROM THE SHAVER OR THE CANNULA FITTING. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19449452 ↗
• MalfunctionJun 3, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY NO ASPIRATION WITH THIS TUBING COULD BE ACHIEVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19447856 ↗
• MalfunctionJun 3, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING ACL RECONSTRUCTION WHILE UTILIZE OF THE ARTHROSCOPIC PUMP DUAL-WAVE THE WATER DIDN'T HAVE THE CORRECT CIRCULATION, AND THERE WAS AN ISSUE WITH THE OUTFLOW KIT. THE RED PUMP (WASTE) TUBE WAS INVERTED WITH THE TRANSPARENT ONE (CANNULA OUTFLOW) AND THE WATER WENT BACK ON THE SURGICAL FIELD. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446263 ↗