FMS 283573Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 10886705017010), received between May 4, 2018 and Sep 15, 2026 — classified as 133 malfunctions.

The most frequently reported specific device problem is “Break” (59 reports).

2 other recalls cover devices cleared under the same FDA submission (K954465); 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 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777993 ↗
• MalfunctionApr 29, 2026Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SCREW ON THE FOOT PEDAL (FMS VUE/NEXTRA) DEVICE THAT HOLDS THE WASH BUTTON WAS MISSING. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE THE BLOOD STOP PUSH BUTTON AND ITS SCREW WERE MISSING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035826 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT THE FOOT PEDAL (FMS VUE/NEXTRA) DEVICE HAD BROKEN LEFT AND RIGHT BUTTONS. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 24998127 ↗
• MalfunctionMar 26, 2026Material Fragmentation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE FOOT PEDAL DEVICE WAS FRACTURED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE BROKE. 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 24700045 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING PRE-OP SETUP FOR AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE PEDALS OF THE FOOT PEDAL(FMS VUE/NEXTRA) HAS BROKEN OFF THE. 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 24394116 ↗
• MalfunctionFeb 6, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE FOOT PEDAL DEVICE REVERSE PEDAL WAS BROKEN. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS DROPPED AND BROKEN AND THE INTERFACE CABLE HAD STOPPED WORKING AFTER A SURGICAL PROCEDURE. 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 24280139 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT THE FOOT PEDAL(FMS VUE/NEXTRA) DEVICE RIGHT PEDAL WAS BROKEN. THE PLASTIC PART WAS BROKEN. 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 23923557 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT THE FOOT PEDAL(FMS VUE/NEXTRA) DEVICE REVERSE PEDAL WAS BROKEN OFF. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 23691555 ↗
• MalfunctionNov 20, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE FOOT PEDAL DEVICE WAS BROKEN (TWO+ PIECES) : DEVICE FRACTURED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS BROKEN. 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 23610361 ↗
• MalfunctionSep 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BUTTONS OF THE FOOT PEDAL (FMS VUE/NEXTRA) DEVICE CAME OFF WHEN IT FELL AND THE BUTTONS COULD NOT BE REATTACHED. THIS EVENT DID NOT OCCUR DURING SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018329 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT THE FOOT PEDAL(FMS VUE/NEXTRA) DEVICE HAD AN UNDETERMINED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT ONE OF THE THREE PEDALS WAS FOUND BROKEN IN TWO PIECES. 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 22881971 ↗
• MalfunctionJul 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FOOT PEDAL DEVICE CORD WAS DETACHED. THE EVENT OCCURRED OUTSIDE OF A SURGICAL PROCEDURE. 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 22536121 ↗
• MalfunctionJul 16, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE FOOT PEDAL(FMS VUE/NEXTRA) DEVICE STOPPED WORKING MID CASE AND THERE WAS A LOUD BEEPING NOISE. 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 22518800 ↗
• MalfunctionJul 10, 2025Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FOOT PEDAL (FMS VUE/NEXTRA) DEVICE WAS FRAYED. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE FELL APART. 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 22470839 ↗
• MalfunctionJun 25, 2025Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE FOOT PEDAL DEVICE STOPPED WORKING. 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 22328550 ↗
• MalfunctionJun 12, 2025Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT WHILE USING THE FOOT PEDAL(FMS VUE/NEXTRA) DEVICE ALONG WITH FMS VUE PUMP DEVICE, THE PUMP HAD TO BE SWITCHED OUT DURING A KNEE SCOPE. ACCORDING TO THE REPORTER, THE ACTUAL IRRIGATION PART CONTINUED TO WORK, BUT THE SHAVER FUNCTION STOPPED RESPONDING AS WELL AS THE FOOT PEDAL. IT WAS REPORTED THAT THE SHAVER HANDPIECE DEVICE WAS SWITCHED OUT TO ANOTHER PUMP AND IT WORKED FINE, BUT THE PEDAL WAS NOT RESPONSIVE AND THE HAND CONTROL FEATURE ON THE SHAVER HAD TO BE USED TO FINISH THE CASE. 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 22192720 ↗
• MalfunctionJun 9, 2025Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE WHILE USING THE FOOT PEDAL DEVICE WOULD NOT COMMUNICATE TO THE FMS BOX TO COMPLETE THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE OPERATED INTERMITTENTLY. 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 22166691 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT DURING RETURN INSPECTION IT WAS OBSERVED THAT THE RIGHT FOOT PEDAL (FMS VUE/NEXTRA) WAS BROKEN OFF. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367225 ↗
• MalfunctionJan 9, 2025Break; Use of Device Problem; Break; Use of Device Problem

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING BIOMED, IT WAS OBSERVED THAT (2X) FOOT PEDAL(FMS VUE/NEXTRA) DEVICE LEFT PEDAL WAS BROKEN(NOT WORKING) ALONG WITH A VAPR3 FOOTSWITCH *EA DEVICE PEDAL MISSING A BUTTON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE LEFT PEDAL WAS BROKEN, THE BROKEN PIECE WAS NOT RETURNED. 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 21110564 ↗
• MalfunctionJan 9, 2025Break; Use of Device Problem; Break; Use of Device Problem

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING BIOMED, IT WAS OBSERVED THAT (2X) FOOT PEDAL(FMS VUE/NEXTRA) DEVICE LEFT PEDAL WAS BROKEN(NOT WORKING) ALONG WITH A VAPR3 FOOTSWITCH *EA DEVICE PEDAL MISSING A BUTTON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE LEFT PEDAL WAS BROKEN, THE BROKEN PIECE WAS NOT RETURNED. 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 21110559 ↗
• MalfunctionNov 25, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE FOOT PEDAL DEVICE STOPPED WORKING. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT 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 20773388 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED FROM SWITZERLAND THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE REVERSE FOOT PEDAL BROKE OFF THE FOOT PEDAL (FMS VUE/NEXTRA) DEVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751092 ↗
• MalfunctionOct 24, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE FMS 5-WAY FOOT PEDAL DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: CORD DAMAGED AND INTERMITTENT OPERATION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT 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 20522283 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING PRE-SURGERY ON (B)(6) 2024 A PIECE OF THE FOOT PEDAL DEVICE SNAPPED OFF. 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 20437817 ↗
• MalfunctionOct 8, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE FOOT PEDAL (FMS VUE/NEXTRA) WAS ¿BUSTED¿ AND WOULD NOT WORK. IT WAS REPORTED THAT THE RIGHT-SIDE PEDAL LOOKS TO BE PUSHED INSIDE THE UNIT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE RIGHT PEDAL LEVER WAS BROKEN. 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 20400334 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954465. One submission often covers many models, so check the product and lot details in each record.

• Z-0658-2016 · Nov 20, 2015 · Terminated
  FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
• Z-0192-2014 · Aug 29, 2013 · Terminated
  DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the ar