Arthrex® AR-6215Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867039025), received between Sep 4, 2024 and Dec 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Increase in Pressure” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Increase in Pressure; Increase in Pressure

  ON (B)(6) 2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN ARTHREX PUMP OVER PRESSURED. AFTER ABOUT AN HOUR AND A HALF OF BEING USED, THE PUMP HAD A SUDDEN INCREASE IN PRESSURE, IT WENT TO 1500 ML/MIN. THE SURGEON WAS NOTIFIED OF THE INCREASE IN PRESSURE AND DIMMED IT OKAY TO PROCEED WITH THE SURGERY. THE CASE WAS COMPLETED WITH NO OTHER CHANGED TO THE ARTHREX PUMP. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 11/25/2024: THE PART NUMBER FOR THE PUMP IS UNKNOWN. THIS WAS DISCOVERED DURING A RIGHT ACLR PROCEDURE. THE PUMP WAS USED WITH THE AR-6215 Y-TUBING ADAPTER DOUBLE SPIKE. THE PUMP WAS SET AT 35ML/MIN THEN INCREASED TO 50ML/MIN. THE SETTING HAD A SUDDEN CHANGE TO 1500ML/MIN. THERE WERE NOT ALARMS OR ERROR MESSAGES PRESENT PRIOR TO OR DURING THE EVENT. THE SURGERY WAS ABORTED.

  Patient problems: Insufficient Information

  MAUDE report 20929651 ↗
• InjurySep 4, 2024Increase in Pressure; Increase in Pressure

  ON 07/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6480 PUMP IS NOISY AND ROTATING AT A HIGH SPEED. THIS OCCURRED DURING USE IN A CASE THE PATIENT SUFFERED AN EXTRAVASATION EVENT DUE TO THE OVERPRESSURE. THE CUSTOMER ABORTED THE CASE IMMEDIATELY. THEY WERE ABLE TO RECTIFY THE ISSUE WITH THE PATIENT, AND THE PATIENT IS REPORTED TO BE FINE. OUTCOME: AS A RESULT OF THE MALFUNCTION, THE PATIENT'S LEG BECAME FILLED WITH FLUID BECAUSE THE DEVICE DID NOT DETECT THE PRESSURE POINT AND CONTINUED OPERATING AT A HIGH SPEED. PROCEDURE WAS AN ARTHROSCOPIC BTB ACL REPAIR. IT WAS ABORTED BEFORE ANY MAJOR PORTION OF THE CASE COULD BE PERFORMED. PER THE RN IN THE ROOM THE PUMP WAS SET TO THE KNEE SETTING WHICH IS 35. YES, EXTRAVASATION DID OCCUR BUT THE FLUID WAS NOT REMOVED. IT REABSORBED. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND WAS DISCHARGED THE NEXT DAY WITH NO SIGNS OF COMPARTMENT SYNDROME. RECOVERY HAS BEEN UNEVENTFUL.

  Patient problems: Extravasation

  MAUDE report 20135028 ↗