FMS 284508Recalls & reported problems

Summary

The FDA's MAUDE database contains 304 adverse event reports that list this exact device (DI 10886705023066), received between Dec 15, 2017 and Jul 27, 2026 — classified as 8 injuries, 296 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (80 reports).

3 other recalls cover devices cleared under the same FDA submission (K951843); they may or may not involve this specific model.

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 304 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046263 ↗
• MalfunctionJul 27, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022519 ↗
• MalfunctionApr 16, 2026Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE INFLOW TUBING FMS VUE DEVICE HAD WATER BEGIN TO COME OUT THROUGH SEVERAL HOLES (IT WAS BROKEN). 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. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899876 ↗
• MalfunctionApr 2, 2026Improper Flow or Infusion

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING RIGHT KNEE ARTHROSCOPY SURGERY, THE INFLOW TUBING FMS VUE DEVICE AND THE FMS VUE II PUMP-SHAVER BOX DEVICE ISSUED A "LOW PRESSURE" WARNING. SUPPLY AND DISCHARGE LINES WERE CHECKED AND NO LEAKS WERE DETECTED. IT WAS REPORTED THAT TOWARD THE END OF SURGERY, DURING THE FLUID DRAINAGE PROCESS FROM THE OPERATING AREA, MASSIVE TISSUE SWELLING REMAINED AROUND THE KNEE JOINT. NO INFORMATION WAS PROVIDED ON MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Swelling/ Edema

  MAUDE report 24769362 ↗
• MalfunctionMar 25, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE INFLOW TUBING FMS VUE DEVICE 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 TUBE. THE IRRIGATION WATER WAS STOPPED, THE INFLOW TUBE WAS REMOVED AND REPLACED WITH A NEW ONE. 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690688 ↗
• MalfunctionMar 20, 2026Overfill; Improper Flow or Infusion

  THIS IS REPORT OF 1 OF 2 OF (B)(4). TUBING: IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE IT WAS OBSERVED THAT WHILE USING THE INFLOW TUBING FMS VUE DEVICE, THE IRRIGATION TUBE WAS CONNECTED AND WHEN THE SURGEON PROCEEDED TO PURGE THE IRRIGATION TUBE IN THE PUMP, THE PRESSURE WOULD DROP TO 1 AND THE RESERVOIR WAS COMPLETELY FILLED. MINUTES LATER THE PRESSURE WOULD RETURN TO NORMAL, AND IT WOULD LOOSE PRESSURE AGAIN. SHUTTLE: THE SPECIALIST RECOVERED THE POINT THROUGH THE IDEAL SUTURE SHUTTLE RIGHT 45: WHEN THE SUTURE WAS RAISED, THE CHIA (WIRE) WAS BROKEN WITHOUT ANY TRACTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF A DELAY TO THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651147 ↗
• MalfunctionFeb 25, 2026Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE INFLOW TUBING FMS VUE 24PK BROKE AND THE PERFUSION FLUID LEAKED. THERE WAS NO SURGICAL DELAY. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441109 ↗
• MalfunctionFeb 4, 2026Overfill; Calibration Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE PUMP DID NOT PROPERLY CALIBRATE WITH THE INFLOW TUBING FMS VUE HOSE AND THE RESERVOIR DID NOT CONTROL THE AMOUNT OF SOLUTION IN IT. THERE WERE NO REPORTS OF SURGICAL DELAY. 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 24259964 ↗
• MalfunctionFeb 4, 2026Improper Flow or Infusion

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, PERFUSION FLUID FAILED TO FLOW THROUGH THE FMS VUE II PUMP-SHAVER BOX DEVICE AND INFLOW TUBING FMS VUE 24PK DEVICE, AND PRESSURE COULD NOT BE APPLIED, SO THE SURGERY WAS SUSPENDED. IT WAS REPORTED THAT THE PROBLEM IMPROVED AFTER THE DEVICE WAS RESTARTED, BUT THE ISSUE PERSISTED. THERE WERE NO DELAYS TO THE 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 24257663 ↗
• MalfunctionJan 12, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INFLOW TUBING FMS VUE DEVICE HAD A SUCTION SYSTEM FAILURE. IT WAS REPORTED THAT THE SUCTION WAS NOT PERFORMING EVEN AFTER CHECKING THE VACUUM. 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 24032151 ↗
• MalfunctionJan 6, 2026Overfill

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE INFLOW TUBING FMS VUE 24PK DEVICE, THE PUMP EQUIPMENT WAS INSTALLED, PLAY-ROOM WAS GIVEN TO FILL THE CHAMBER AND IT IS COMPLETELY FILLED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976816 ↗
• MalfunctionNov 19, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE A HOLE WAS NOTICED IN THE INFLOW TUBING FMS VUE PUMP, WHICH CAUSED THE HOSE TO OPEN, CAUSING A LARGE LEAK OF SALINE SOLUTION. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592415 ↗
• MalfunctionNov 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INFLOW TUBING FMS VUE EQUIPMENT SHOWED LEAKAGE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM OR DELAY IN SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493194 ↗
• MalfunctionNov 5, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE INFLOW TUBING FMS VUE DEVICE WAS BEING USED ALONG WITH A FMS VUE PUMP DEVICE WHEN THE RESERVOIR IS PRE-FILLED NORMALLY, BUT WHEN THE SPECIALIST STARTED THE PROCEDURE THE CONSOLE STARTED TO LOWER THE PRESSURE AND THIS FILLED THE RESERVOIR COMPLETELY, THE DOCTOR INFORMED THAT THIS IS THE HOSE AND REQUESTS TO CHANGE IT FOR ANOTHER ONE IT WORKS NORMALLY, BUT THE CONSOLE AFTER A CERTAIN TIME LOWERS THE PRESSURE AND THE WATER STOPS FLOWING, THE HOSE WAS SENT FOR REVIEW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479793 ↗
• MalfunctionOct 31, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE INFLOW TUBING FMS VUE DEVICE BEGAN LEAKING SERUM. IT WAS UNKNOWN IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441630 ↗
• MalfunctionOct 24, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE WHILE USING THE INFLOW TUBING FMS VUE 24PK DEVICE, THE INTERMED TUBESET SCHKVLVE 24PK DEVICE AND AN UNK - FLUID MANAGEMENT DEVICE, IT WAS OBSERVED THAT FROM THE BEGINNING OF THE PROCEDURE, THE ROOM NURSE FLUSHED THE TUBING, AND THE FLUSH NEVER STOPPED, DELIVERING A SIGNIFICANT AMOUNT OF FLUID INTO THE KNEE. THIS RESULTED IN MASSIVE INFILTRATION IN THE PATIENT'S THIGH AND CALF. AT NO POINT DID A PRESSURE ALARM MANIFEST. THE INFLOW TUBING FMS VUE 24PK DEVICE PUMP WAS CHANGED AND THE OVERPRESSURE ISSUE WAS NOT RESOLVED. THERE WAS A THIRTY MINUTE DELAY TO THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 OF (B)(4).

  Patient problems: Extravasation

  MAUDE report 23383117 ↗
• MalfunctionOct 21, 2025Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING PRE-SURGERY FOR ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, IT WAS OBSERVED THAT AFTER 2X INFLOW TUBING FMS VUE 24PK DEVICES WERE SET, ARTHROMATIC (PERFUSATE) WAS FLOWED, BUT THE DEVICE WAS DAMAGED CAUSING ARTHROMATIC TO LEAK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345799 ↗
• MalfunctionOct 21, 2025Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING PRE-SURGERY FOR ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, IT WAS OBSERVED THAT AFTER 2X INFLOW TUBING FMS VUE 24PK DEVICES WERE SET, ARTHROMATIC (PERFUSATE) WAS FLOWED, BUT THE DEVICE WAS DAMAGED CAUSING ARTHROMATIC TO LEAK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345797 ↗
• MalfunctionOct 15, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE UNSPECIFIED SURGICAL PROCEDURE THE INFLOW TUBING FMS VUE DEVICE HAD A HOLE IN THE TUBE CAUSING WATER TO LEAK AND MAKING IT UNUSABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303271 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON A SHOULDER JOINT FOR A ROTATOR CUFF TEAR, IT WAS DISCOVERED THAT AN ATTEMPT WAS MADE TO SET THE INFLOW TUBING FMS VUE DEVICE IN THE FMS. IT WAS CONFIRMED THAT THE TUBE, WHICH ROTATED INTO THE ROTOR, WAS BROKEN AT THE JOINT JUST ABOVE THE TANK. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 23301781 ↗
• MalfunctionSep 17, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT DURING THE INTERVENTION OF AN UNSPECIFIED SURGICAL PROCEDURE, THE INFLOW TUBING FMS VUE TUBING DEVICE WAS PIERCED AT THE LEVEL OF THE ROLLERS OF THE ARTHROPUMP. IT WAS REPORTED THAT THE OPERATION HAD TO BE INTERRUPTED FOR TUBING CHANGE, HOWEVER THE EXACT AMOUNT OF DELAY WAS NOT 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 23072573 ↗
• MalfunctionSep 12, 2025Increase in Pressure; Use of Device Problem; Increase in Pressure; Use of Device Problem

  IT WAS REPORTED THAT THE INFLOW TUBING FMS VUE 24PK DEVICE DID NOT WORK AS IT SHOULD. AT THE AIR OUTLET THAT PRESSURES THE WATER, THE VALVE WAS NOT WORKING. THE EQUIPMENT WAS LEFT WITH THE UNCONTROLLED SERUM AND ALMOST RETURNED WATER TO THE PUMP. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037236 ↗
• MalfunctionAug 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AT THE BEGINNING OF AN UNKNOWN SURGICAL PROCEDURE. IT WAS OBSERVED THAT WHEN CONNECTING THE PUMP, THE INFLOW TUBING FMS VUE 24PK DEVICE FLUSHING TUBE STARTED TO LEAK. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827561 ↗
• MalfunctionAug 7, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INFLOW TUBING FMS VUE 24PK DEVICE PART THAT WAS INSERTED INTO THE PERFUSION FLUID WAS DIRTY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742294 ↗
• MalfunctionAug 6, 2025Leak/Splash; Device Damaged Prior to Use; Leak/Splash; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN OPENING AND REASSEMBLING THE NFLOW TUBING FMS VUE DEVICE, IT WAS FOUND THAT THE HOSE WAS PHYSICALLY DAMAGED. A TEST REVEALED THAT THE HOSE WAS LEAKING, PREVENTING THE PUMP FROM FUNCTIONING PROPERLY. IT HAD NOT BEEN TAMPERED WITH NOR SUBJECTED TO ANY FORCE THAT COULD HAVE CAUSED THE DAMAGE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF 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 22731160 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951843. One submission often covers many models, so check the product and lot details in each record.

• Z-0191-2014 · Aug 29, 2013 · Terminated
  DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to
• Z-1948-2011 · Dec 3, 2010 · Terminated
  DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management
• Z-1946-2011 · Dec 3, 2010 · Terminated
  DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management