Arthrex® AR-6410Recalls & reported problems
Arthrex, Inc. · MAIN PUMP TUBING · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex arthroscopy pump tubing set has 117 adverse event reports, with 36 injuries and no deaths. Many describe pressure rising or extra fluid flowing into the surgical site, and some describe fluid leaking into tissue and causing swelling. 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
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00888867118010), received between Dec 20, 2016 and Aug 31, 2026 — classified as 36 injuries, 81 malfunctions.
The most frequently reported specific device problem is “Increase in Pressure” (22 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
- Increase in Pressure22
- Pressure Problem15
- Defective Device11
- Excess Flow or Over-Infusion7
- Material Deformation7
- Pumping Problem6
- Leak/Splash5
- No Flow5
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- Swelling/ Edema22
- Extravasation15
- Insufficient Information14
- Swelling4
- Burning Sensation2
- Muscle Weakness/Atrophy2
- Nerve Damage2
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518693 ↗MalfunctionAug 27, 2026Increase in Pressure
On (b)(6) 2026, it was reported by a Sales Representative via (b)(6) that an AR-6430 cassette and tubing set elevated pressure towards the end of the case like it was not connected. This occurred during use in a knee scope case with no patient effect.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50481836 ↗MalfunctionAug 27, 2026Increase in Pressure
On (b)(6) 2026, it was reported by a Sales Representative via (b)(6) that an AR-6430 cassette and tubing set elevated pressure towards the end of the case like it was not connected. This occurred during use in a knee scope case with no patient effect.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50481088 ↗MalfunctionAug 3, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50115037 ↗MalfunctionJan 23, 2026Material Twisted/Bent
ON 09-JAN-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING WAS NOT FUNCTIONING ADEQUATELY, THE BLACK STRAW (NEOPRENE) WAS NOT NORMAL AND WAS SLIGHTLY BENT CAUSING THE SOLUTION VOLUME TO INCREASE CONTINUOUSLY. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24163548 ↗MalfunctionDec 2, 2025Pressure Problem; Pressure Problem
ON 11/12/2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-07123836 THAT THE LAVAGE SENT AN OVERPRESSURE OF FLUID WHEN SWITCHING CANULAS VIA THE AR-6410 MAIN PUMP TUBING DURING A SHOULDER SCOPE. THERE WAS SOME DISTENTION FROM THE SURGICAL SITE, BUT THE PATIENT WAS NOT ADVERSELY AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23697576 ↗MalfunctionDec 1, 2025Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation
ON 11/06/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-07117911 THAT AN AR-6410 MAIN PUMP TUBING MEMBRANE WAS CRUSHED AND IT DIDN'T WORK NORMALLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682463 ↗MalfunctionDec 1, 2025Pressure Problem; Pressure Problem
ON 11/11/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING HAD ABNORMAL PRESSURE AND THE PRODUCT CONTINUED TO SPIN. THE TUBING WAS SWAPPED AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23681610 ↗MalfunctionNov 19, 2025Increase in Pressure; Material Deformation; Increase in Pressure; Material Deformation
ON 10/30/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 MEMBRANE WAS CRUSHED AND WATER FLOWED AT A HIGH PRESSURE. THE PROCEDURE WAS COMPLETED WITH REPLACED TUBE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23593019 ↗MalfunctionAug 25, 2025No Flow; No Flow
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING WATER DID NOT FLOW. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882696 ↗MalfunctionAug 20, 2025Suction Problem; Pressure Problem; Suction Problem; Pressure Problem
ON 08/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6480 DW ARTHROSCOPY PUMP HAD TROUBLE WITH SUCTION AND PRESSURE AND AR-8305 SYNERGY RESECTION CONSOLE SHP NOT READING WHEN PLUGGED IN. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850490 ↗MalfunctionJul 18, 2025Collapse; No Flow; Collapse; No Flow
ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2025 WHERE IT WAS STATED THIS EVEN OCCURRED ON (B)(6) 2025. AN ARTHREX PUMP WAS NOT UTILIZED DURING THIS EVENT. THE PUMP AND TUBING WERE USED TO COMPLETE THE CASE. THERE WAS NO CLAMP/PRESSURE TEST DONE.
Patient problems: Insufficient Information
MAUDE report 22541989 ↗MalfunctionMar 20, 2025Infusion or Flow Problem; Infusion or Flow Problem
ON 03/05/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING AFTER LINKED TO PUMP, WATER SHOULD BE FILLED HALF THEN STARTED TO CIRCULATE. BUT IN THIS CASE WATER WAS FILLED FULLY. NO CIRCULATION. THIS WAS DISCOVERED DURING AN RCR CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21651139 ↗MalfunctionMar 19, 2025Use of Device Problem; No Flow; Use of Device Problem; No Flow
ON 4TH MARCH 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-6410, ARTHROSCOPY MAIN PUMP TUBING, WAS NOT DETECTED AT THE CONSOLE. WATER WAS UNABLE TO RUN THROUGH. THIS WAS DETECTED DURING A LEFT ANKLE ARTHROSCOPY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY OPENING A NEW AR-6410. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21642900 ↗MalfunctionMar 17, 2025No Flow; No Flow
ON 02/27/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING WATER DID NOT FLOW. THIS WAS DISCOVERED DURING USE IN A CASE. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21618850 ↗InjuryMar 10, 2025Increase in Pressure; Increase in Pressure
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 21558967 ↗MalfunctionMar 7, 2025Increase in Pressure; Increase in Pressure
ON 19TH FEBRUARY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-6410, ARTHOSCOPY MAIN PUMP TUBING, IT FAILED TO FUNCTION. THE PUMP WAS INDICATING THAT THE PRESSURE ON THE TUBING WAS TOO HIGH EVEN THOUGH THERE WERE NO KINKS NOTED ALONG THE TUBING AFTER INSPECTION. AFTER SWAPPING OUT THE TUBING, THE PUMP FUNCTIONED AS NORMAL. THIS WAS DISCOVERED DURING USE IN A MENISCUS REPAIR OF THE RIGHT KNEE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE USE OF A REPLACEMENT PUMP TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21550353 ↗MalfunctionFeb 11, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06761474 THAT AN AR-6410 MAIN PUMP TUBING MEMBRANE WAS CRUSHED AND COULD NOT BE USED. THIS WAS DISCOVERED DURING USE IN A CASE. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21357377 ↗MalfunctionFeb 10, 2025Obstruction of Flow; Obstruction of Flow
ON 01/27/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 ARTHROSCOPY MAIN PUMP TUBING WAS NOT SENDING SERUM TO THE CAVITY. THIS OCCURRED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21344379 ↗MalfunctionDec 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 11/13/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING MEMBRANE WAS STUCK, CAUSING THE PUMP TO OVER-SPIN. THIS WAS DISCOVERED BEFORE USE IN A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913762 ↗MalfunctionDec 6, 2024Pressure Problem; Pressure Problem
ON 11/06/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING MBRANE WAS CRUSHED, CAUSING THE PRESSURE TO BECOME ABNORMALLY HIGH AND THE PATIENT'S LEG BECAME SWOLLEN. THIS WAS DISCOVERED DURING USE IN A CASE. THE SURGEON STOPPED USING THE PRODUCT AND THE IRRIGATION WAS PERFORMED BY (B)(4). ADDITIONAL INFORMATION REQUESTED TO THE REP.
Patient problems: Swelling/ Edema
MAUDE report 20870054 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2024 , IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING MEMBRANE WAS DEFLATED WHEN OPENED. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20614566 ↗MalfunctionOct 22, 2024Material Twisted/Bent; Material Twisted/Bent
ON 10/04/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(6) THAT AN AR-6410 ARTHROSCOPY MAIN PUMP TUBING SENSOR WAS BENT. THIS OCCURRED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2024 WHEN THE PROCEDURE WAS STARTED, THE CONSUMABLE WAS PLACED IN THE EQUIPMENT, AND THE SOLUTION WAS PURGED, THERE WERE NO PROBLEMS OR ALERTS UNTIL THE JOINT WAS ENTERED AND IT DID NOT WORK PROPERLY SINCE ALMOST NONE OF THE SOLUTION PASSED, AFTER OBTAINING ANOTHER PIPE TO CHANGE, THE CONSUMABLE WAS LOOKED AT IN DETAIL AND IT WAS OBSERVED THAT THE SENSOR WAS BENT OR DAMAGED INTERNALLY, WHICH IS IMPOSSIBLE FOR IT TO HAVE BEEN DAMAGED DURING THE SURGERY SINCE THE DAMAGE WAS INTERNAL.
Patient problems: Insufficient Information
MAUDE report 20507401 ↗MalfunctionOct 8, 2024Increase in Pressure; Patient Device Interaction Problem; Increase in Pressure; Patient Device Interaction Problem
ON 9/11/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-6410 MAIN PUMP TUBING MALFUNCTIONED DURING A SHOULDER SURGERY. THE TUBING WAS CONNECTED TO AN AR-6485 (SERIAL NUMBER: (B)(6)). THE PUMP WAS SET AT A FLOW RATE OF 20. DURING SURGERY, THE PATIENT'S SHOULDER BECAME EXCESSIVELY SWOLLEN. THE SURGERY WAS COMPLETED WITHOUT REPLACING THE PUMP TUBING. NO INFORMATION WAS AVAILABLE REGARDING WHETHER THE MEMBRANE HAD COLLAPSED, WHAT TREATMENT WAS GIVEN TO THE PATIENT, OR WHETHER THE HOSPITAL STAY WAS EXTENDED.
Patient problems: Swelling/ Edema
MAUDE report 20396738 ↗MalfunctionSep 12, 2024Increase in Pressure; Increase in Pressure
ON 8/26/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6410 PUMP TUBING PRESSURE SUDDENLY INCREASED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200682 ↗
Other ARTHROSCOPE devices
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- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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