Arthrex® AR-6480Recalls & reported problems
Arthrex, Inc. · DW ARTHROSCOPY FLUID MANAGEMENT DEV · Class 2
Quick summary
This Arthrex AR-6480 is an arthroscopy fluid management device that controls fluid flow during arthroscopic surgery. The 937 reports mostly describe pressure problems, unusually high fluid pressure or flow, suction failures and intermittent power loss. Some mention swelling from fluid that escaped into surrounding tissue. The reports include no deaths and 93 injuries, and no recalls name this device. Reports fell to 59 over the last year from 114 in the year before.
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
- 949
- Deaths reported
- 0
- Injuries reported
- 93
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 949 adverse event reports that list this exact device (DI 00888867039377), received between Jul 13, 2016 and Sep 30, 2026 — classified as 93 injuries, 856 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (189 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 Problem189
- Increase in Pressure115
- Defective Device85
- Infusion or Flow Problem64
- Suction Failure48
- Intermittent Loss of Power44
- Unexpected Shutdown30
- No Flow28
Patient problems
- No Clinical Signs, Symptoms or Conditions703
- Insufficient Information123
- Swelling/ Edema47
- Extravasation36
- Swelling13
- No Code Available8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- No Known Impact Or Consequence To Patient6
Recent adverse event reports
The 25 most recent of 949 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Increase in Pressure
On 11-Sept-2026, it was reported by a Sales Representative via (b)(4) that an AR-6480 pump is building high pressure. This occurred during use in a case with no patient effect.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946593 ↗MalfunctionSep 29, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938269 ↗MalfunctionSep 28, 2026Suction Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924179 ↗MalfunctionSep 28, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915768 ↗MalfunctionSep 28, 2026Increase in Pressure
It was reported that during the ankle arthroscopy, significant swelling of the ankle occurred within a few seconds shortly after the procedure began. The device was then turned off and restarted, but the problem recurred, and the pressure rose to over 350 mmHg and did not drop again. During surgical preparation before the surgery, the pump was connected and set up as usual. The setting for the ankle joint (35 mmHg) was selected on the pump. During priming, it was already noticed that the water pressure was unusually high. Nevertheless, the surgery was started. The surgery was finished successfully with a new device with the same part number (pump and tubing set were replaced). It was not necessary to switch the surgical technique or do a second surgery.Update 16-Sep-2026 - Further information was received:The extravasation was limited to the patient¿s ankle and was treated with compression. The patient did not develop a compartment syndrome.
Patient problems: Extravasation
MAUDE report 50913426 ↗MalfunctionSep 18, 2026Pressure Problem
On 02-Sep-2026, a Sales Representative reported via (b)(4) that an AR-6480 DualWave Pump was not regulating pressure properly. This occurred during a case. There was no additional information provided, and additional information has been requested.
Patient problems: Insufficient Information
MAUDE report 50816916 ↗InjurySep 17, 2026Increase in Suction
It was reported that during a knee arthroscopy in the middle of the application it was noticed, that the pump on the inflow side rotated extremely quickly and the bags emptied extremely quickly. At first everything worked normally and all of a sudden, for no apparent reason, the pump created an extreme vacuum. The surgical assistant then inspected the tubings and finally decided to take one of the used pumps that was still on site. When the Arthrex representative inspected the pump afterwards, the tubing was installed incorrectly, but it was unclear whether this did not happen at the moment when the surgical assistant inspected the tubing, as the assistant had also touched the inflow side, according to their own information. The device was tested afterwards and everything worked perfectly. The patient had severe swelling after the surgery. 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 08-Sep-2026A user report was provided on the 8th of September 2026 stating that there was a dysfunctional arthropump apparatus with overpressure. Change of tubing. Turn off and r
Patient problems: Compartment syndrome
MAUDE report 50803628 ↗MalfunctionSep 14, 2026Increase in Pressure
On (b)(6) 2026, it was reported by a Sales Representative via (b)(6) that an AR-6480 pump pressure set at 40 and running over 100 no matter what was done on field. This occurred during use in a case with no patient effect.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752278 ↗MalfunctionSep 14, 2026Increase in Pressure
On (b)(6) 2026, it was reported by a Sales Representative via (b)(6) that an AR-6480 pump pressure set at 40 and running over 100 no matter what was done on field. This occurred during use in a case with no patient effect.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752081 ↗MalfunctionSep 10, 2026Suction Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716684 ↗MalfunctionSep 10, 2026Suction Problem
It was reported that during a surgery a suction problem has occurred. Per complaint reporter there was no harm for patient, operator or third party. No further information received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713132 ↗MalfunctionSep 8, 2026Increased Pump Speed; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669424 ↗MalfunctionSep 8, 2026Increased Pump Speed; Noise, Audible
On 24-Aug-2026, it was reported by a Sales Representative via (b)(4) that an AR-6480 pump was connected to outflow tubing and a shaver and pumped faster than normal. This occurred during use in a case with no patient effect. Issue was observed during operation of the dual pump system, with abnormal pump speed and excessive noise reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669209 ↗MalfunctionSep 2, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567809 ↗MalfunctionAug 26, 2026Increase in Pressure; Pumping Stopped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456786 ↗InjuryAug 18, 2026Excess Flow or Over-Infusion
It was reported that during an anterior cruciate ligament surgery the pump infused an unusually large amount of fluid into the knee at a very high rate. As a result, the pump operated irregularly, which caused the tubing to be pushed forward. The surgery was finished successfully with new tubing sets (AR-6420 & AR-6425). It was not necessary to switch the surgical technique or do a second surgery.***Update (b)(6) 2026:Further information was received on (b)(6) 2026 that no compartment syndrome occurred. The excess fluid was removed by irrigation (rinse), manual expression of fluid from the knee, and the use of a suction tube.
Patient problems: Extravasation
MAUDE report 50306505 ↗MalfunctionAug 18, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301588 ↗MalfunctionAug 18, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300654 ↗MalfunctionAug 17, 2026Increase in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50282339 ↗MalfunctionAug 14, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254297 ↗MalfunctionAug 14, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254158 ↗MalfunctionJul 30, 2026Increase in Pressure
Patient problems: Joint Dislocation
MAUDE report 50083099 ↗MalfunctionJul 30, 2026Increase in Pressure
On 10-June-2026, it was reported by a Sales Representative via (b)(4) that an AR-6480 pump over pressured and expanded the shoulder joint. This occurred during use in a shoulder arthroscopy case with no patient effect.The pressure was set to 50. The pump shut off and an unknown alarm sounded. A different pump was used to complete the procedure. There was no revision to remove extra fluid and the patient was not kept at the facility for fluid removal.
Patient problems: Joint Dislocation
MAUDE report 50083092 ↗MalfunctionJul 28, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057646 ↗MalfunctionJul 28, 2026Excess Flow or Over-Infusion; Improper Flow or Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057468 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.