Arthrex® AR-6415Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867039131), received between Feb 18, 2025 and Aug 18, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50301000 ↗
• MalfunctionApr 28, 2026Failure to Pump

  IT WAS REPORTED THAT DURING THE HIP ARTHROSCOPY, THE BLACK PRESSURE VALVE ON THE INFLOW TUBE DID NOT INFLATE. THE PUMP STOPPED OPERATING DUE TO A HIGH-PRESSURE ALARM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015034 ↗
• MalfunctionApr 9, 2026Increase in Pressure

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY SURGERY THE DEVICE BUILT UP A LOT OF PRESSURE AND WOULDN¿T STOP IN ANY WAY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24833521 ↗
• MalfunctionMar 25, 2026Increase in Pressure

  IT WAS REPORTED THAT DURING A POSTERIOR AND ANTERIOR CRUCIATE LIGAMENT SURGERY THE INFLOW TUBES OF THE ARTHROSCOPIC PUMP BECAME OVERPRESSURIZED AND BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. THIS LINE WAS CREATED FOR THE TUBING THAT WAS USED WITH THE REPORTED DEVICE. UPDATE 09-MAR-2026: THE TUBING THAT WAS USED WITH THE PUMP ARE THE AR-6415 LOT: N5032. THE PUMP PRESSURE WAS SET AT 60 MMHG PRESSURE. NO ALARM OR ERROR MESSAGE RECEIVED DURING THE USE JUST AN UNUSUAL HIGH PRESSURE AND CONTINUOUS FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688260 ↗
• MalfunctionMar 12, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE INFLOW TUBING CHAMBER STARTED FILLING UP WITH A LOT OF WATER, RESULTING IN A MASSIVE SPIKE IN THE FLOW. THIS RESULTED THAT THE PATIENTS SHOULDER SWELLING UP, MAKING THE SURGERY VERY DIFFICULT. 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.

  Patient problems: Swelling/ Edema

  MAUDE report 24579534 ↗
• InjuryNov 5, 2025Excess Flow or Over-Infusion; Infusion or Flow Problem; Excess Flow or Over-Infusion; Infusion or Flow Problem

  FURTHER INFORMATION WAS RECEIVED THAT THE REPORTED ISSUE OCCURRED DURING A SHOULDER ARTHROSCOPY. THE CUSTOMER FURTHER REPORTED THAT NO HARM HAS OCCURRED HOWEVER THE EVENT COULD HAVE RESULTED IN VASCULAR AND NEUROLOGICAL COMPRESSION AND THEREFORE IT WAS DECIDED TO ABORT THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476716 ↗
• MalfunctionOct 29, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE TUBING HAS STOPPED REGULATING THE PRESSURE AND IT APPEARED THAT THE PRESSURE REGULATOR (BLACK TUBE) MAY HAVE BURST OR FAILED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414800 ↗
• MalfunctionOct 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A SURGERY THERE WAS A LEAK DETECTED IN THE PIPE INSIDE THE ROLLER PUMP. 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. UPDATE AVOE 09-OCT-2025 AVOE IT WAS CONFIRMED THAT THE ARTHREX PUMP AR-6480 WAS USED WITH THE INITIALLY REPORTED TUBING. THE SN OF THE DEVICE IS (B)(6), SINCE THE CUSTOMER HAS TWO PUMPS AND THEIR USE IS NOT TRACKED. THIS IS THE FIRST TIME SUCH AN INCIDENT HAS OCCURRED, EVEN THOUGH IT IS A DEVICE THAT IS USED VERY OFTEN. THE PROBLEM OCCURRED AS SOON AS IT WAS CONNECTED. NO SIMILAR INCIDENTS SINCE. UPDATE AVOE 09-OCT-2025 AVOE A USER REPORT WAS PROVIDED BY THE AUTHORITY FOR THIS CASE. THERE WAS A SIGNIFICANT WATER LEAKAGE FROM THE ARTHROPUMP SYSTEM. THE LEAK WAS DETECTED IN THE TUBING INSIDE THE ROLLER PUMP. VIDEO COLUMN DISPLAYED ¿FLOODED,¿ REQUIRING EMERGENCY SHUTDOWN DUE TO ELECTRICAL HAZARDS AS ALL POWER CABLES WERE SUBMERGED IN SALINE SOLUTION. THE PATIENT WAS NOT AFFECTED, BUT AN EMERGENCY SHUTDOWN AND THE DISCONNECTION OF THE ARTHROSCOPY COLUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404416 ↗
• MalfunctionJul 29, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE FLUID PRESSURE AROUSE CONSIDERABLY. PRESSURES WERE SET AT 30, BUT IT GOT REALLY HIGH AND THE SURGEON HAD TO CHANGE TO ANOTHER INFLOW TUBING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 22649426 ↗
• InjuryFeb 18, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE PUMP DELIVERED TO MUCH FLUID INTO THE PATIENT. IT WAS FURTHER REPORTED THAT THE PUMP WORKED FOR 30MIN WITHOUT ISSUES AND SUDDENLY STARTED TO INCREASE THE FLOW. THIS RESULTED IN A SWOLLEN THROAT AND COULD NOT BE EXTUBATED AT THE MOMENT. NO INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: Extravasation

  MAUDE report 21395983 ↗