FMS VUE II 284004Recalls & reported problems

Summary

The FDA's MAUDE database contains 562 adverse event reports that list this exact device (DI 10886705027934), received between Mar 23, 2018 and Sep 30, 2026 — classified as 40 injuries, 522 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (185 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 562 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Leak/Splash; Moisture Damage; Power Problem

  It was reported that during in-house engineering evaluation, it was determined that the FMS VUE II PUMP-SHAVER BOX device had a leak ¿ liquid. It was initially reported that preoperatively to an unknown procedure, it was observed that the device could not be turned on because there was moisture inside the device. It was reported that there were no delays to the surgical procedure as a spare device was available for use. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948650 ↗
• MalfunctionSep 28, 2026Display or Visual Feedback Problem; Increase in Pressure; Output Problem; Noise, Audible

  It was reported that during an unspecified arthroscopic procedure, the FMS VUE II PUMP-SHAVER console device, an error alarm sounded and irrigation stopped. The product displayed a high-pressure notification, and the arthroscopic field repeatedly turned red. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917589 ↗
• MalfunctionSep 21, 2026Increase in Pressure

  It was reported that during an unspecified surgical procedure it was observed that the pressure of the FMS VUE II PUMP-SHAVER BOX device was too high. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838848 ↗
• MalfunctionSep 14, 2026Improper Flow or Infusion; Output Problem; Power Problem

  It was reported that during an unspecified arthroscopic procedure the FMS VUE II PUMP-SHAVER BOX device shows low pressure. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757651 ↗
• MalfunctionSep 9, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699622 ↗
• MalfunctionSep 9, 2026Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available

  It was reported that during service and evaluation, it was determined that the FMS VUE II PUMP-SHAVER BOX device was Cracked, Stripped/Worn/Twisted/Cross Threaded, had Corrosion/Rusting/Pitting, and Inadequate Pressure. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693179 ↗
• MalfunctionSep 3, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595988 ↗
• MalfunctionAug 27, 2026Increase in Pressure; Improper Flow or Infusion; Output Problem

  It was reported that during an unspecified surgical procedure, during the middle of the surgery, the fluid flow suddenly increased and began splashing from the incision site. Adjustments were made by decreasing and increasing the pressure; however, eventually only a small amount of fluid, at the level of dripping droplets, could be delivered even when pressure was applied. The procedure was completed successfully. There was no surgical delay and no patient harm reported. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482891 ↗
• MalfunctionAug 27, 2026Increase in Pressure; Overfill

  It was reported that during an unspecified surgical procedure it was observed that the FMS VUE II PUMP-SHAVER BOX device was switching to low or high pressure. It was further observed that the tubing could not be filled with water because the flow did not stop as it should when reaching a specific level. There were no reported adverse consequences to the patient. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50473513 ↗
• MalfunctionAug 21, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50375929 ↗
• MalfunctionAug 17, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that during service and evaluation, it was determined that the FMS VUE II device had Inadequate Pressure. It was noted in the service order that the device had no Customer Allegation initially reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50277761 ↗
• MalfunctionAug 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177385 ↗
• MalfunctionAug 3, 2026Electrical /Electronic Property Problem; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114738 ↗
• MalfunctionJul 27, 2026Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025361 ↗
• MalfunctionJul 27, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50012205 ↗
• MalfunctionJul 27, 2026Break; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50005832 ↗
• MalfunctionMay 11, 2026Overfill; Output Problem

  IT WAS REPORTED THAT AT THE BEGINNING OF AN UNSPECIFIED PROCEDURE, THE FMS VUE II PUMP STARTED WELL BUT SUDDENLY ONLY THE RESERVOIR WAS FILLED, MAKING AN EXTRA FILLING AND EXCEEDING THE LEVEL. GIVEN THAT WHERE THE MACHINE BEGAN TO FAIL, IT SHUT DOWN BY ITSELF, BLOCKED THE OPERATION OF THE SHAVER, WITHOUT ANY SOLUTION OF THE PUMP, IT ONLY WORKS OF THE SHAVER ONLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION BUT IT CAUSED A DELAY IN THE SURGICAL TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137250 ↗
• MalfunctionMay 4, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT FMS VUE II PUMP-SHAVER BOX DEVICE WAS LEAKING LIQUID. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069309 ↗
• MalfunctionApr 29, 2026Leak/Splash

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE FMS VUE II PUMP-SHAVER BOX DEVICE HAD A LIQUID LEAK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031993 ↗
• MalfunctionApr 29, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE FMS VUE II PUMP-SHAVER BOX DEVICE HAD INADEQUATE PRESSURE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028620 ↗
• MalfunctionApr 24, 2026Increase in Pressure

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE FMS VUE II PUMP-SHAVER BOX DEVICE HAD HIGH PRESSURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978992 ↗
• MalfunctionApr 17, 2026Difficult to Open or Close; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE IT WAS OBSERVED THAT THE LEFT PUMP TUBING DOOR OF THE FMS VUE II PUMP-SHAVER BOX DEVICE DID NOT FULLY OPEN ON ITS OWN. IT WAS REPORTED THAT WHEN PRESSURE WAS APPLIED THE DOOR DID FULLY OPEN. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915950 ↗
• MalfunctionApr 16, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, APPROXIMATELY 5 MINUTES AFTER THE START OF THE SURGERY, A WATER LEAK WAS DISCOVERED FROM THE FMS INFLOW SECTION. UPON REMOVING THE INFLOW TUBE COVER, A CRACK WAS FOUND IN THE INFLOW TUBING FMS DEVICE. THE IRRIGATION WATER WAS STOPPED, THE INFLOW TUBE WAS REMOVED AND REPLACED WITH A NEW ONE. THE SURROUNDING WET AREAS WERE WIPED WITH GAUZE TO REMOVE MOISTURE, THE TUBE WAS SET UP ACCORDING TO THE PROCEDURE, AND THE RUN BUTTON WAS PRESSED AGAIN. WATER BEGAN TO FLOW, BUT THE LOW PRESSURE INDICATOR FLASHED ON THE FMS VUE II PUMP-SHAVER BOX DEVICE WITHOUT DETECTING PRESSURE. THE TUBE WAS REATTACHED, AND THE JOINTS OF EACH TUBE AND THE FMS CONNECTION POINTS WERE CHECKED. THE POWER WAS TURNED OFF THE FMS, THE TUBING WAS REPLACED AGAIN WITH A NEW ONE, SET UP ACCORDING TO THE PROCEDURE, AND REATTACHED. IT THEN OPERATED NORMALLY. THE INITIAL FMS SETUP WAS PERFORMED BY THE CIRCULATING NURSE BEFORE ENTERING THE ROOM, AND IT WAS CONFIRMED THAT THERE WAS NO DAMAGE TO THE TUBE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904677 ↗
• MalfunctionApr 15, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE FMS VUE II DEVICE HAD INADEQUATE PRESSURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884477 ↗
• MalfunctionApr 6, 2026Electrical /Electronic Property Problem; Increase in Pressure

  IT WAS REPORTED THAT THE AUDIBLE ALARM OF THE FMS VUE II PUMP-SHAVER BOX DEVICE WAS ACCOMPANIED BY ERROR MESSAGE FC04. IT WAS REPORTED THAT APPARENTLY THIS WAS A HIGH-PRESSURE ERROR. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792093 ↗