Arthrex® AR-6475Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00888867039346), received between Dec 9, 2016 and Aug 11, 2026 — classified as 14 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (13 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Electrical Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50207293 ↗
• MalfunctionMar 10, 2025Increase in Pressure; Pressure Problem; Increase in Pressure; Pressure Problem

  ON 02/19/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING EXPERIENCED AN OVERPRESSURE EVENT. THIS WAS DISCOVERED DURING USE IN A KNEE SURGERY CASE. THE PUMP USED IN THE SURGERY WAS AN AR-6475 CONTINUOUS WAVE III. DURING SURGERY, THE AMOUNT OF WATER INCREASED ABNORMALLY. THE PATIENT'S KNEE BECAME SWOLLEN, AND THE PATIENT WAS UNABLE TO BEND HIS LEG. FINALLY, THE SURGERY WAS CALLED OFF. ADDITIONAL SURGERY IS BEING CONSIDERED AT A LATER DATE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Swelling/ Edema

  MAUDE report 21558095 ↗
• MalfunctionJan 22, 2025Increase in Pressure; Increase in Pressure

  ON 12/27/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6475 ARTHROSCOPY PUMP DID NOT SET OFF AN ALARM WHEN IT WAS TRYING TO OVERPRESSURE WHEN CLAMPED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209481 ↗
• MalfunctionNov 22, 2024Suction Failure; Suction Failure

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6475 ARTHROSCOPY PUMP WAS NOT GETTING ANY SUCTION. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759101 ↗
• MalfunctionJun 19, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE PUMP WAS REPORTED TO BE FAULTY AND WON'T STOP. THE USER REPORTING THAT TURNING IT ON WAS OKAY, HOWEVER THE STOP BUTTON IS NOT WORKING. INTERMITTENT FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567539 ↗
• MalfunctionJun 12, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PLIXIGLASS COVER IS DEFECTIVE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518789 ↗
• MalfunctionJun 11, 2024Mechanical Problem; Mechanical Problem

  ON 04/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6475 ARTHROSCOPY PUMP ROLLER ASSEMBLY SPINNING EXCESSIVELY WHEN THE PRESSURE IS SET TO 40. 1.1 NO ERROR MESSAGE ON THE SCREEN, BUT THE FACILITY COULD NOT GET THE ROLLER TO STOP SPINNING UNLESS THE PRESSURE WAS SET TO 20. 1.2 THIS WAS DURING A CASE, HOWEVER, THE PATIENT WAS NOT ADVERSELY AFFECTED. THEY FINISHED THE CASE SUCCESSFULLY BY KEEPING THE PRESSURE SET TO 20. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511403 ↗
• MalfunctionJun 10, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PRESSURE AND FLOW CANNOT BE ADJUSTED AS THE CONTROL PANEL DOES NOT RESPOND. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498196 ↗
• MalfunctionMay 23, 2024Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED ON 09/26/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6475 PUMP IS CUTTING OUT IN THE MIDDLE OF SURGERY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387714 ↗
• MalfunctionMay 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE TOUCHPAD/SCREEN OF THE PUMP NO LONGER DISPLAYS ANYTHING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 19321903 ↗
• MalfunctionMay 15, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP DOES NOT STOP PUMPING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321564 ↗
• MalfunctionMay 6, 2024Pressure Problem; Pressure Problem

  ON 01/26/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-6475 ARTHROSCOPY PUMP IS CAUSING SWELLING, THE PRESSURE READINGS ARE NOT ACCURATE. THIS OCCURRED IN AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE SALES REPRESENTATIVE VIA PHONE ON 02/01/2022 : THIS EVENT OCCURRED IN A SHOULDER SCOPE. ARTHREX TUBING WAS USED WITH THE PUMP. THERE WAS LITTLE SWELLING THAT WENT DOWN NATURALLY ON ITS OWN.

  Patient problems: Insufficient Information

  MAUDE report 19248735 ↗
• MalfunctionMay 2, 2024Pressure Problem; Pressure Problem

  ON 04/21/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6475 CWIII ARTHROSCOPY PUMP HAD AN ISSUE, OPEN TUBING, WHEN CLAMPED DID NOT GIVE PRESSURE FAULT. THE ISSUE OCCURRED IN A CASE AND WAS VERIFIED BY BIO AS AN ISSUE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231003 ↗
• MalfunctionApr 30, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PUMP LOCKING LATCH IS LOOSE, BENT AND NOT CLOSING PROPERLY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213448 ↗
• MalfunctionApr 29, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DEVICE OFTEN DID NOT SWITCH OFF AND CONTINUED TO RUN. 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. UPDATE AVOE 29-SEP-2021: IT WAS CONFIRMED THAT THE ERROR WAS IMMEDIATELY NOTICED AND THEREFORE NO PATIENT INJURY OCCURRED. IT WAS FURTHER CONFIRMED THAT NO CLAMP TEST WAS PERFORMED IN ADVANCE AND THE NEOPRENE SLEEVE WAS COMPRESSED. THE TUBING AR-6420 (LOT: Z1006) WAS USED WITH THE REPORTED PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200385 ↗
• MalfunctionApr 26, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP IS WORKING CONTINOUSLY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193260 ↗
• MalfunctionApr 26, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE ONLY RUNS AT A PRESSURE OF 60 OR HIGHER. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19190557 ↗
• MalfunctionApr 26, 2024Increased Pump Speed; Increased Pump Speed

  ON 04/03/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6475 ARTHROSCOPY PUMP WAS RUNNING AT A FASTER SPEED THAN INTENDED. THIS OCCURRED DURING A CASE WHERE THERE WERE NO ERROR MESSAGES CORRESPONDING TO THE PROBLEM. THE SPEED OF THE PUMP WAS DESCRIBED AS "REALLY FAST," EVEN WITH THE CLAMP OFF, AND IT WAS CONTINUOUSLY RUNNING.

  Patient problems: Insufficient Information

  MAUDE report 19190436 ↗
• MalfunctionFeb 7, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE IS DEFECTIVE, IT IS SPINNING PERMANENTLY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE, 04-MAR-2021 -SAC. RECEIVED FURTHER INFORMATION THAT THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18657549 ↗
• MalfunctionJan 16, 2024Increase in Pressure; Increase in Pressure

  ON 6/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-6475 WAVE III PUMP, DESPITE BEING SET TO NORMAL, THE FLUID WAS BEING PUMPED INTO THE JOINT AT AN EXPONENTIAL RATE AND COULD NOT BE REDUCED. THIS WAS DISCOVERED DURING A KNEE ARTHROSCOPY PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Swelling/ Edema

  MAUDE report 18516772 ↗
• MalfunctionJan 10, 2024Pressure Problem; Pressure Problem

  ON 3/27/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-6475 PUMP HAD LESS THAN ADEQUATE PRESSURE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486712 ↗
• MalfunctionDec 29, 2023No Display/Image; No Display/Image

  ON 02/23/2022 IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-6475 PUMP SCREEN DOES NOT WORK. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO PATIENT HARM. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418439 ↗
• MalfunctionDec 29, 2023Pressure Problem; Pressure Problem

  ON 01/19/2022 IT WAS REPORTED BY A ARTHREX REPRESENTATIVE VIA SEMS THAT AN AR-6475 PUMP DISPLAYS PRESSURE FAULT WHEN IN USE. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. NO PATIENT HARM. TS: CHECKED WITH A MANOMETER AND NOTICED THAT THE PRESSURE INDICATED AND THE MEASURED PRESSURE IS OFF. REQUESTED ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418178 ↗
• MalfunctionDec 28, 2023Pressure Problem; Pressure Problem

  ON 12/20/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6475 PUMP IS EXPERIENCING PRESSURE ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18413411 ↗
• MalfunctionDec 11, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED DURING A SHOULDER REPAIR THE PUMP STARTED RUNNING REALLY FAST WITHOUT ANY CHANGE TO THE PUMP. THE REP STOPPED THE UNIT BEFORE ANY INJURY OCCURRED. IT WAS REPLACED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES AND THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300383 ↗