FMS VUE 284002Recalls & reported problems

Summary

The FDA's MAUDE database contains 829 adverse event reports that list this exact device (DI 10886705020591), received between Dec 28, 2017 and Sep 30, 2026 — classified as 13 injuries, 816 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (146 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 829 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Computer Software Problem; Display or Visual Feedback Problem

  It was reported that during an unspecified arthroscopic procedure the FMS VUE PUMP device, that the pump not functioning normally. lights are blinking and not working. 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 50952132 ↗
• MalfunctionSep 30, 2026Increase in Pressure; Use of Device Problem

  It was reported that prior to surgery, the pressure sensor on the FMS VUE device went off. It was further reported that the high-pressure light came on. 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 50945349 ↗
• MalfunctionSep 25, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902700 ↗
• MalfunctionSep 25, 2026Improper Flow or Infusion

  It was reported that during an unspecified surgical procedure it was observed that the FMS VUE PUMP device was not maintaining pressure. It was reported that the device was an allocation pump. It was reported that there was a spare device available for use. It was reported that there were no delays nor patient harm. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899445 ↗
• MalfunctionSep 23, 2026Unintended Movement; Noise, Audible

  It was reported that the FMS VUE PUMP device was constantly pulling liquid through when not requested and was making a noise. It was not reported if the event occurred during a surgical procedure. 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 50866632 ↗
• MalfunctionSep 21, 2026Use of Device Problem; Infusion or Flow Problem

  It was reported that during setup the right-side shaver pump was not working and had no suction. Staff changed the set and the problem persisted. They swapped devices with a spare and a new set to proceed. The patient was not involved. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839951 ↗
• MalfunctionSep 11, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740293 ↗
• MalfunctionSep 10, 2026Display or Visual Feedback Problem; Mechanical Jam

  It was reported that during annual service, it was observed that the FMS VUE PUMP device had a mechanical problem, it could not swing back. The "Blood Stop", "Fill Chamber" and "Shaver Suction Setting" LEDs could not be illuminated. 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 unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718637 ↗
• MalfunctionSep 4, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615652 ↗
• MalfunctionAug 31, 2026Improper Flow or Infusion; Mechanical Jam; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525790 ↗
• MalfunctionAug 20, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50355601 ↗
• MalfunctionAug 12, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219228 ↗
• MalfunctionAug 4, 2026Increase in Pressure; Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131134 ↗
• MalfunctionAug 4, 2026Increase in Pressure; Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130993 ↗
• MalfunctionAug 4, 2026Increase in Pressure; Device Remains Activated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130932 ↗
• MalfunctionMay 19, 2026Leak/Splash; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE FMS VUE PUMP DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 25219910 ↗
• MalfunctionMay 8, 2026Use of Device Problem; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE FMS VUE PUMP DEVICE THAT THE OUTFLOW WHEEL IS NOT WORKING. 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 25129670 ↗
• MalfunctionApr 23, 2026Nonstandard Device; Increase in Pressure; Device Remains Activated

  IT WAS REPORTED THAT DURING THE START OF HIP SURGERY/SCOPE, THE STAFF INDICATED THAT THE MS VUE PUMP WASN'T REGISTERING PRESSURE PROPERLY AND KEPT RUNNING WHEN IT SHOULDN'T HAVE. THEY ENDED UP FILLING THE TUBING THROUGH THE CHAMBER AND BACK UP THE TUBING. THE WHEEL WAS NOT RUNNING TO MAINTAIN PRESSURE. THE RESOLUTION WAS TO SWAP FOR ANOTHER PUMP, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974972 ↗
• MalfunctionApr 2, 2026Overfill; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC HIP PROCEDURE THAT THE FMS VUE PUMP DEVICE 2 HAD THE SAME ISSUE, THE FILL CHAMBER WAS FILLING ENTIRELY WITH FLUID BEFORE GENERATING A LOW-PRESSURE WARNING AND TURNING OFF THE PUMP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770191 ↗
• MalfunctionApr 2, 2026Overfill; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC HIP PROCEDURE THAT THE FMS VUE PUMP DEVICE 2 HAD THE SAME ISSUE, THE FILL CHAMBER WAS FILLING ENTIRELY WITH FLUID BEFORE GENERATING A LOW-PRESSURE WARNING AND TURNING OFF THE PUMP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770190 ↗
• MalfunctionMar 26, 2026Increase in Pressure

  IT WAS REPORTED THAT DURING AN UNKNOWN SHOULDER ARTHROSCOPIC PROCEDURE THAT THE FMS VUE PUMP DEVICE THE PUMP PRESSURE WAS READING EXTREMELY HIGH (300MMHG) AND KEPT DECREASING AND INCREASING ERRATICALLY. TUBING WAS INSPECTED AND NOT HOLES OR OCCLUSIONS WERE FOUND. 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 24702303 ↗
• MalfunctionMar 18, 2026Display or Visual Feedback Problem; Increase in Pressure

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, WHILE PRIMING THE FILL CHAMBER OF THE FMS VUE PUMP, THE PRESSURE WAS NOT MAINTAINED IN THE LINES AND THE AIR WAS BEING INTRODUCED IN THE LINES. IT IS UNKNOWN IF 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 24625465 ↗
• MalfunctionMar 17, 2026Increase in Pressure

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE FMS VUE PUMP DEVICE WAS NOT HOLDING PRESSURE. IT IS UNKNOWN IF 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 24615860 ↗
• MalfunctionMar 16, 2026Increase in Pressure

  IT WAS REPORTED THAT THE FMS VUE PUMP DID NOT HOLDING PRESSURE AS IT SHOULD.  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 24608203 ↗
• MalfunctionMar 11, 2026Display or Visual Feedback Problem; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE FMS VUE PUMP DEVICE PUMP IS NOT CLEARING OUT THE JOINT, IT ONLY SEEMS TO CLEAR IT OUT WHEN THE SHAVER IS BEING USED. 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 24571770 ↗