Arthrex® AR-6435Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867118089), received between Oct 3, 2023 and Jun 14, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Partial Blockage; Partial Blockage

  ON 05/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6435 OUTFLOW SET HAS A CLOG BEHIND THE OUTFLOW CASSETTE. THIS WAS THE END EFFECT, AS THE CLOG ALMOST WRAPPED THE ENTIRE CURVE AND COULD NOT BE RELIEVED. MINOR CASE DELAYS NO PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537867 ↗
• MalfunctionJun 8, 2024Break; Break

  ON 05/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6435 OUTFLOW SET IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19494682 ↗
• MalfunctionJun 6, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ON 09/23/2021 IT WAS REPORTED BY A SALE REPRESENTATIVE VIA SEMS THAT AN AR-6435 DW OUTFLOW TUBING WAS NOT WORKING PROPERLY, OUTFLOW WAS NOT DETECTED. THIS WAS DISCOVERED DURING A PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19477322 ↗
• MalfunctionFeb 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2/8/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6435 DW OUTFLOW TUBE SET TUBING LOOKED LIKE IT WAS STILL ON THE SHAVER. HOWEVER, WHEN THEY WENT TO MOVE IT, THE PIECE OF TUBING THAT CONNECTS TO THE SHAVER WAS ON IT BUT THE WHOLE TUBING WAS COMPLETELY OUT AS IF THE SEALANT CAME APART. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799201 ↗
• MalfunctionFeb 6, 2024Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE PUMP SPEED INCREASES UNCONTROLLABLY. THE CUSTOMER HAS REPORTED THAT THE ISSUE COULD BE SOLVED WITH THE THIRD TUBING SET AND FINISHED THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 04-FEB-2021 DW IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALREADY IN THE SURGERY ROOM BUT THE RELATED PUMP WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18653230 ↗
• MalfunctionOct 3, 2023Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  ON (B)(6) 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 17862871 ↗