Arthrex® AR-6485Recalls & reported problems
Arthrex, Inc. · SYNERGY CW4 ARTHROSCOPY PUMP · Class 2
Quick summary
This Arthrex Synergy CW4 arthroscopy pump is a device that feeds fluid into a joint during arthroscopic surgery. Many of the 113 reports describe the pump not regulating pressure correctly, pressure building up on its own, or the unit losing power or shutting down. Some reports describe fluid leaking into the surrounding tissue, causing swelling. The reports include 4 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 117
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00888867251182), received between May 18, 2021 and Sep 29, 2026 — classified as 4 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (39 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Pressure Problem39
- Increase in Pressure16
- Defective Device9
- Intermittent Loss of Power7
- Excess Flow or Over-Infusion5
- Key or Button Unresponsive/not Working4
- Unexpected Shutdown4
- No Flow3
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- Insufficient Information14
- Extravasation8
- Swelling/ Edema5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inflammation1
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Increase in Pressure
On (b)(6) 2026, it was reported by a Distributor via an Email that for 1 unit of (b)(6), ReDeuce Pump Tubing w/Connector, 8' Long, its tubing did not work properly. The water pressure surged, spraying everywhere.This was detected during a Scope ACL on (b)(6) 2026. The procedure was completed successfully by replacing the tubing. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932987 ↗MalfunctionSep 3, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594287 ↗MalfunctionSep 2, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570045 ↗MalfunctionSep 2, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569755 ↗MalfunctionAug 31, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518692 ↗MalfunctionAug 27, 2026Mechanical Jam
On (b)(6) 2026, it was reported by a Sales Representative via (b)(4) that an AR-6485 pump wont stay locked. This occurred during use in a case with no patient effect.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50474771 ↗MalfunctionJul 31, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50102713 ↗MalfunctionJul 31, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50102010 ↗MalfunctionMar 13, 2026Pressure Problem
IT WAS REPORTED THAT DURING A SURGERY THE PUMP SUDDENLY BUILT-UP PRESSURE CONTINUOUSLY WITHOUT STOPPING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS RECEIVED. UPDATE (B)(6) IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING AN ARTHROSCOPY SURGERY. 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 24590246 ↗MalfunctionFeb 11, 2026Pressure Problem
IT WAS REPORTED BY A MEDICAL TECHNICIAN THAT DURING INSPECTION IT WAS FOUND THAT THE PAT REGULATES PRESSURE EVEN WHEN THERE IS RESISTANCE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. UPDATE ON 4-FEB-2025: FURTHER INFORMATION WAS RECEIVED ON 26-JAN-2026 THAT THE FAILURE OCCURRED DURING AN ARTHROSCOPIC KNEE SURGERY. THE DEVICE DID NOT REGULATE THE PRESSURE CORRECTLY. THE SURGERY ON (B)(6) 2025 WAS COMPLETED SUCCESSFULLY WITH THE DEVICE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317110 ↗MalfunctionJan 8, 2026Excess Flow or Over-Infusion
ON 18-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-6485 SYNERGY CW4, ARTHROSCOPY PUMP DELIVERED AN EXCESSIVE AMOUNT OF FLUID INTO THE SHOULDER DURING A, ROTATOR CUFF REPAIR PROCEDURE. THE PUMP WAS SET TO 50, AND AT THE START OF THE CASE, SIGNIFICANT FLUID ACCUMULATION RESULTED IN EXTRAVASATION. THE SURGICAL TEAM REMOVED THE EXTRAVASATION TO THE BEST OF THEIR ABILITY, AND THE PROCEDURE CONTINUED USING A DIFFERENT PUMP. IT IS UNKNOWN WHETHER THE PATIENT WAS KEPT OVERNIGHT.
Patient problems: Extravasation; Insufficient Information
MAUDE report 24003435 ↗MalfunctionJun 20, 2025Pressure Problem; Pressure Problem
ON 06/02/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMP WAS PRODUCING A PRESSURE FAULT ERROR CODE. THE ISSUE IS BELIEVED TO BE ISOLATED TO THE PUMP, AS BOTH TUBE SETS ARE WORKING ON DIFFERENT CONSOLES WITH NO ERROR CODE.
Patient problems: Insufficient Information
MAUDE report 22298803 ↗MalfunctionApr 21, 2025Pressure Problem; Pressure Problem
ADDITIONAL INFORMATION WAS RECEIVED ON 04/16/2025: THIS OCCURRED ON (B)(6) 2025, AND THE PROCEDURE NAME IS UNKNOWN. THERE WAS NO DELAY IN THE CASE, NOR WAS ADDITIONAL ANESTHESIA ADMINISTERED. THE ARTHREX TUBING USED WITH THE PUMP IS UNKNOWN. THE PUMP SETTINGS AT THE TIME OF THE EVENT WERE "40." NO CLAMP OR PRESSURE TEST WAS CONDUCTED BEFOREHAND. THERE WAS A BEEPED ERROR MESSAGE, BUT THE DISPLAY DID NOT MENTION ANY ALARM MESSAGE. NO PHOTOS WERE TAKEN, AND NO SALES REP WAS PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876739 ↗MalfunctionApr 18, 2025Pressure Problem; Pressure Problem
ON 04/02/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMP STOPS RANDOMLY WITH PRESSURE FAULT ERROR. THE PRESSURE FAULT OCCURRED DURING THE CASE. THERE WAS NO CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 21865435 ↗MalfunctionFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON 01/30/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMP WAS EXPERIENCING INACCURATE PRESSURE READINGS.
Patient problems: Insufficient Information
MAUDE report 21393789 ↗MalfunctionFeb 11, 2025Pressure Problem; Pressure Problem
ON 01/21/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMPS PRESSURE WILL JUMP INTERMITTENTLY AND THE HAND CONTROL WILL NOT CONNECT TO THE PUMP. THIS OCCURRED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356853 ↗MalfunctionFeb 11, 2025Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY A "CRITICAL ERROR" HAS OCCURRED. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21353939 ↗MalfunctionJan 16, 2025Increase in Pressure; Increase in Pressure
ON 12/20/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMP WAS OVER PRESSURE RISING IN JOINT. NO REPORTED PATIENT HARM. NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21170235 ↗MalfunctionJan 3, 2025Increase in Pressure; Increase in Pressure
ON 12/06/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMP DISPLAYED AN OVERPRESSURE ERROR WHEN IN USE. THE UNIT WAS CONNECTED IN A CASE, AND THE PRESSURE ERROR CODE WOULD NOT LET THE UNIT WORK AS INTENDED. THE UNIT WOULD AUTOMATICALLY STOP WHILE THE PATIENT WAS IN THE ROOM. THE UNIT WAS SWITCHED TO ANOTHER, AND THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ADVERSE EVENTS OR HARM TO THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067183 ↗MalfunctionOct 17, 2024Output Problem; Output Problem
ON 09/19/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMP WAS NOT PUMPING AS IT WAS SET TO PUMP, THEY PUT IN 700 ML FL THROUGH IT, BUT THE MACHINE SAID 1200 ML. THIS OCCURRED DURING THE CASE, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20472608 ↗MalfunctionOct 4, 2024Pumping Problem; Pumping Problem
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA *(B)(4) THAT AN AR-6485 PUMP WAS PUMPING 500 ML LESS. NOT AWARE OF A CASE, NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20368589 ↗InjurySep 23, 2024Pressure Problem; Pressure Problem
ON 11TH SEPTEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2024 AT AROUND 3.30PM, SWELLING IN THE CHEST CAVITY (UP TILL THE NECK) WAS DETECTED BY THE ANESTHETIST SHORTLY AFTER THE INSERTION OF THE FIRST 2 ANCHORS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ARTHREX EMPLOYEE HAD CHECKED THAT ALL THE DEVICES (I.E., SCOPE, PUMP, SHAVER AND RF) WERE CONNECTED PROPERLY AND NOTICED THAT THE PUMP WAS ALREADY AT 65MMHG BUT WAS UNSURE WHO HAD SET THE PRESSURE TO 65MMHG. SHE OBSERVED THROUGH THE SCOPE AND FOUND OUT THAT THE VISIBILITY WAS POOR AND THERE WERE MAJOR IMPEDIMENTS TO LOCATE THE CUFF TEAR. AS A RESULT, THE SURGEON THEN INSTRUCTED TO ACTIVATE LAVAGE ON MULTIPLE OCCASIONS AND WAS ABLE TO LOCATE THE CUFF TEAR. HE THEN PREPARED THE FOOTPRINT AND INSERTED THE FIRST TWO ANCHORS ON THE MEDIAL ROW. THIS WAS WHEN THE SWELLING WAS DETECTED BY THE ANESTHETIST WHO ALERTED THE SURGEON AND QUESTIONED HIM HOW MUCH LONGER HE REQUIRED TO COMPLETE THE SURGERY. THE SURGEON RESPONDED THAT HE NEEDED ANOTHER 30 MINUTES TO FINISH UP THE SURGERY AND DECIDED TO PRESS ON. THE ARTHREX EMPLOYEE THEN INFORMED THE SURGEON THAT SHE WOULD DECREA
Patient problems: Extravasation
MAUDE report 20283741 ↗MalfunctionSep 9, 2024Pressure Problem; Pressure Problem
IT WAD REPORTED THAT DURING A ROTATOR CUFF SURGERY THE TUBING WORKED GREAT BEGINNING OF THE SURGERY, BUT AFTER A WHILE THE PUMP IN COMBINATION WITH THE TUBING STARTED TO PUMP 1000ML/PER MINUTE. DURING SURGERY THE TUBING WAS CHANGED AND IT WORKED GREAT. 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 20175071 ↗MalfunctionSep 5, 2024Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE PUMP OR SUCTION REGULATOR IS NOT WORKING. THE PUMP IS SUCKING AT A TOO HIGH A SUCTION PRESSURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-6475). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20145929 ↗MalfunctionJul 5, 2024Intermittent Loss of Power; Intermittent Loss of Power
ON 06/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06590763 THAT AN AR-6485 SYNERGY CW4 ARTHROSCOPY PUMP WOULD STOP AND FLOW IN MED CASE. THIS OCCURRED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19680354 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.