FMS 284610Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886705023226), received between Apr 24, 2018 and Jan 28, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Leak/Splash

  IT WAS REPORTED THAT DURING AN ACROMIOPLASTY AND ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHILE USING THE DISP PATIENT SET FMS 24PK DEVICE, WAS CONNECTED TO THE INFUSION PUMP TO START IRRIGATION, AT THE TIME THE SERUM WAS RELEASED, AND AN IMMEDIATE AND LARGE VOLUME LEAK WAS OBSERVED ALONG THE EQUIPMENT, MAKING IT IMPOSSIBLE TO USE IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 24203290 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DISP PATIENT SET FMS OUTFLOW TUBING BEING USED WITH THE FLUID MANAGEMENT SYSTEM (FMS) BROKE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING A DIFFERENT TUBE. IT WAS REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838320 ↗
• MalfunctionOct 1, 2024Break; Leak/Splash; Improper Flow or Infusion; Break; Leak/Splash; Improper Flow or Infusion

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED FROM MEXICO THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE TUBING FROM THE DISP PATIENT SET FMS 24PK AND INFLOW TUBING FMS VUE 24PK DEVICES WAS CORRECTLY PLACED IN THE CONSOLE. HOWEVER, WHEN PURGING THE SYSTEM, WATER BEGAN LEAKING EVERYWHERE, CAUSING THE TUBING TO BREAK AND INSUFFICIENT PRESSURE IN THE SOLUTION DURING THE PROCEDURE. ALTHOUGH THE PROCEDURE WAS COMPLETED, THERE WAS A GENERAL FAILURE IN BOTH BATCHES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347266 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPE PROCEDURE FOR AN OSTRIGONUM REMOVAL THE TWO (X2) INFLOW TUBING FMS VUE DEVICE AND DISP PATIENT SET FMS DEVICE WAS BEING USED WHEN INTERMEDIARY TUBES IN THE INFLOW TUBE AND OUTFLOW TUBE WERE SET UP TO USE FMS TO FLOW WATER; HOWEVER, THE GREEN PLASTIC PART THAT HOOKS THE INFLOW TUBE CAME OFF SEVERAL TIMES AND THE WATER DID NOT FLOW. ALTHOUGH ANOTHER INFLOW TUBE WAS USED, SAME ISSUE OCCURRED. IT COULD NOT BE USED FOR SURGERY. THE SURGEON DONE A SPONTANEOUS SALINE SOLUTION DRIP. THE SALE REP SUSPECTED A SETTING ERROR, SINCE THERE WAS NO PROBLEM WHEN HE ATTENDED SEVERAL SURGERIES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165870 ↗
• MalfunctionDec 11, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE DISP PATIENT SET FMS 24PK DEVICE DID NOT RELEASE WATER OUT OF THE TUBING ALTHOUGH IT WAS SET AS USUAL. THE TUBING WAS EXCHANGED, THE REPLACEMENT DEVICE WAS USED WITH NO ISSUES. 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 18299974 ↗
• MalfunctionNov 16, 2023Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING BEFORE AN ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) PROCEDURE ON 11/9/2023, THE DISP PATIENT SET FMS 24PK DEVICE BLUE CAP ON THE UNCLEAN SIDE OF THE INTERMEDIARY TUBING IN THE INFLOW TUBING COULD NOT BE REMOVED, AND THE SURGEON HAD TO TURN IT WITH PLIERS TO REMOVE. IT WAS REPORTED THAT THEREFORE THE WATER LEAK OCCURRED WHEN THE INTERMEDIARY TUBING WAS CONNECTED TO THE INFLOW TUBING AND WAS PUT INTO OPERATION. 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 18147229 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THREE DISP PATIENT SETS INFLOW TUBES SPLIT WHEN ATTACHED. HOWEVER, WHEN THE FIRST INFLOW TUBE SPLIT, WATER GOT INTO THE MAIN BODY, AND THE MAIN BODY BECAME OUT OF WORK. 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. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012249 ↗
• MalfunctionOct 4, 2023Improper Flow or Infusion; Improper Flow or Infusion

  THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, AN UNKNOWN FLUID MANAGEMENT DEVICE WAS USED WITH THE FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE) DEVICE AND FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/OUT ONE-WAY VALVE (FMS VUE OR FMS DUO) DEVICE. ACCORDING TO THE REPORT, THE WATER DID NOT CIRCULATE PROPERLY AFTER STARTING THE PUMP. IT WAS REPORTED THAT THE WATER WAS NOT FLOWING. IT WAS REPORTED THAT BOTH THE INFLOW TUBE AND OUTFLOW TUBE FINALLY WORKED PROPERLY AFTER THE THIRD USE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869898 ↗
• MalfunctionOct 4, 2023Improper Flow or Infusion; Improper Flow or Infusion

  THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, AN UNKNOWN FLUID MANAGEMENT DEVICE WAS USED WITH THE FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE) DEVICE AND FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/OUT ONE-WAY VALVE (FMS VUE OR FMS DUO) DEVICE. ACCORDING TO THE REPORT, THE WATER DID NOT CIRCULATE PROPERLY AFTER STARTING THE PUMP. IT WAS REPORTED THAT THE WATER WAS NOT FLOWING. IT WAS REPORTED THAT BOTH THE INFLOW TUBE AND OUTFLOW TUBE FINALLY WORKED PROPERLY AFTER THE THIRD USE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869878 ↗
• MalfunctionJul 14, 2023Use of Device Problem; Device Contaminated During Manufacture or Shipping; Use of Device Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE DISTRIBUTOR IN BRAZIL THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/OUT ONE-WAY VALVE (FMS VUE OR FMS DUO) DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WERE SALINE RESIDUES WERE INSIDE THE TUBES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17326627 ↗
• MalfunctionJun 14, 2022Increase in Pressure; Increase in Pressure

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A TENDON FUSION IN THE BICEPS AND ROTATOR CUFF SUTURING PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FLUID DID NOT FLOW PROPERLY CAUSED BY FASTER FLOW SPEED, UNSTABLE PUMPING PRESSURE, AND SUCTION MALFUNCTIONING ON UNKNOWN FLUID MANAGEMENT DEVICE WITH TUBINGS. THE PROCEDURE WAS DELAYED BY 90 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14688903 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE DISP PATIENT SET FMS DEVICE WAS BROKEN AND COULD NOT BE USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13562087 ↗
• MalfunctionFeb 7, 2022Delivered as Unsterile Product; Device Damaged Prior to Use; Delivered as Unsterile Product; Device Damaged Prior to Use

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A CONFERENCE EVENT, IT WAS OBSERVED THAT THE PACKAGING OF THE DISP PATIENT SET FMS 24PK DEVICE CAME OPEN AND DAMAGED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475115 ↗
• MalfunctionJan 24, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN THAILAND THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE DISP PATIENT SET FMS DEVICE WAS BROKEN AND COULD NOT BE USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13337982 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT PREOPERATIVELY TO AN ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VALVE ON THE FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/OUT ONE-WAY WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475828 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED BY THE CUSTOMER IN FRANCE THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE WATER DID NOT COME OUT OF THE IRRIGATION TUBING DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 20 TO 25 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597137 ↗
• MalfunctionMar 31, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE WATER DID NOT COME OUT OF THE IRRIGATION TUBING DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 20 TO 25 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597084 ↗
• MalfunctionOct 16, 2018Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THEIR FMS OUTFLOW TUBING WAS LEAKING THROUGH THE CONNECTIONS. IT WAS NECESSARY TO OPEN ANOTHER PRODUCT TO COMPLETE THE SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970920 ↗
• MalfunctionMay 11, 2018Suction Problem; Suction Problem

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THEY WERE DOING A SHOULDER SCOPE AND DURING THE CASE THE SUCTION FROM THE SHAVER DID NOT WORK , THEY TRIED TO WORK AROUND IT BUT HAD TO CHANGE ALL THE TUBING (OUTFLOW AND THE INFLOW). OPENED UP NEW TUBING TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON (B)(6) 2017 THERE WAS A RESULTING SURGICAL DELAY OF 4 MINS AT MOST NO PATIENT IMPACT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7509395 ↗
• MalfunctionApr 24, 2018Leak/Splash; Leak/Splash

  THE AFFILIATE REPORTED VIA EMAIL THAT PRODUCT "BURST" DURING THE SURGERY THAT HAPPENED ON (B)(6) 2017. IT IS UNKNOWN UNTIL THIS MOMENT IF BOTH PRODUCTS BURST OR JUST ONE. WE ARE VERIFYING THIS INFORMATION YET. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 5-16-2017. TYPE OF PROCEDURE IS UNKNOWN, THIS INFORMATION WAS SENT TO THE SALES REP TO VERIFY. IT IS UNKNOWN IF THE SPLIT IN THE TUBING IS WHERE THE TUBING IS PLACED ON THE ROLLER, THIS INFORMATION WAS SENT TO THE SALES REP. TO VERIFY. IT IS UNKNOWN IF THE PHOTO WAS FOR ONE TUBING OR BOTH, THIS INFORMATION WAS SENT TO THE SALES REP. VERIFY. ANOTHER PRODUCT THAT WAS AVAILABLE IN THE HOSPITAL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7455807 ↗

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-1946-2011 · Dec 3, 2010 · Terminated
  DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management
• 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