FMS DUO 284580Recalls & reported problems

Summary

The FDA's MAUDE database contains 458 adverse event reports that list this exact device (DI 10886705020607), received between Aug 27, 2013 and Dec 2, 2025 — classified as 9 injuries, 449 malfunctions.

The most frequently reported specific device problem is “Break” (75 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 458 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE FMS DUO PLUS FLUID MANAGEMENT SYSTEM DID NOT WORK. IT WAS REPORTED THAT THERE WAS NO DELAY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE HAD EXCESSIVE FLOW. 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 23694220 ↗
• MalfunctionOct 15, 2025Break; Break

  DURING AN IN HOUSE ENGINEERING EVALUATION IT WAS FOUND THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO DEVICE WAS BROKEN IN 2+ PIECES. IT WAS REPORTED INITIALLY FROM THE REPORTER THAT THE DEVICE HAD A BROKEN IRRIGATION SAFETY COVER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302023 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO DEVICE SUCTION SAFETY COVER WAS BROKEN. 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 22861286 ↗
• MalfunctionJul 15, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO DEVICE IRRIGATION COVER WAS BROKEN AND THE LEFT FRONT FOOT WAS MISSING. BOTH HINGES ON THE COVER WERE BROKEN OFF. 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 22509992 ↗
• MalfunctionFeb 24, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE 4580 FMS DUO+ PUMP/SHAVER DEVICE HAD INACCURATE FLUID VOLUME. 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 21444520 ↗
• MalfunctionDec 9, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING SETUP THE 4580 FMS DUO+ PUMP/SHAVER COMBO DEVICE PUMP HAD EXCESS PRESSURE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 20878367 ↗
• MalfunctionSep 25, 2024Use of Device Problem; Improper Flow or Infusion; Use of Device Problem; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE FMS DUO PLUS FLUID MANAGEMENT SYSTEM DEVICE WAS NOT FUNCTIONING PROPERLY. DURING SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: INADEQUATE FLOW AND DEFORMED/BENT. 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 20305291 ↗
• MalfunctionSep 17, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO DEVICE PUMP CHAMBER WAS FILLING/PUMP OVERFLOWED. 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 20234682 ↗
• MalfunctionJun 14, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE AFTER CHECK IT WAS FOUND THAT THE PRESSURE ADJUSTER NEEDED TO BE REPLACED. 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 FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537001 ↗
• MalfunctionJun 2, 2024Use of Device Problem; Overfill; Use of Device Problem; Overfill

  IT WAS REPORTED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE NOT RUNNING PROPERLY. TUBES SETUP. WON'T START THE FILLING PROCESS. JUST BLINKING GREEN LIGHT. WILL FILL CHAMBER BUT, SOMETIMES OVERFILLS. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444727 ↗
• MalfunctionApr 4, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP THAT AT THE END OF AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE SUCTION SIDE OF THE PUMP WOULD NOT ACTIVATE. IT WAS REPORTED THAT THERE WAS NO DELAY TO THE SURGICAL PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039657 ↗
• MalfunctionMar 25, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED FROM AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE HAD PRESSURE LOSS IN THE PUMP. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967535 ↗
• MalfunctionMar 7, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE PUMP ON THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE WOULD NOT DROP IN PRESSURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 18856850 ↗
• MalfunctionMar 6, 2024Overfill; Overfill

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING PRE-SURGERY TESTING ON (B)(6) 2024 IT WAS OBSERVED THAT THE FILL CHAMBER OF THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE WOULD NOT STOP FILLING. IT WAS REPORTED THAT THE FILL CHAMBER CONTINUED TO FILL AND WOULD NOT STOP. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 18846670 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED BY AN AFFILIATE THAT PRIOR TO SURGERY ON (B)(6) 2024, IT WAS OBSERVED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO DEVICE WAS BROKEN WHERE IT WAS HINGED. THIS EVENT DID NOT OCCUR DURING SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796643 ↗
• MalfunctionJan 25, 2024Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE FILL CHAMBER ON THE 4580 FMS DUO+ PUMP/SHAVER COMBO DEVICE DID NOT STOP FILLING. 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 18580463 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE PLASTIC COVER OF THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE WAS BROKEN. IT WAS REPORTED THAT THIS OCCURRED OUTSIDE OF SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): DEVICE FRACTURED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363892 ↗
• MalfunctionDec 19, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY THE J&J EMPLOYEE FROM ITALY THAT AFTER A CHECK ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO DEVICE HAD A DEFECTIVE FLOW. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 18356128 ↗
• MalfunctionNov 28, 2023Suction Problem; Appropriate Device Problem Term/Code Not Available; Suction Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FOUND THAT DURING AN IN HOUSE ENGINEERING EVALUATION THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE HAD A SUCTION FAILURE. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221987 ↗
• MalfunctionNov 2, 2023Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available; Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SERVICE CENTER IN SOUTH AFRICA THAT DURING PREVENTATIVE MAINTENANCE, IT WAS DISCOVERED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO DEVICE HAD AN INADEQUATE PRESSURE. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056616 ↗
• MalfunctionOct 20, 2023Overfill; Calibration Problem; Overfill; Calibration Problem

  IT WAS REPORTED THAT DURING PRE-OP IT WAS OBSERVED THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE WOULD NOT CALIBRATE AND CONTINUED TO OVERFLOW. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974754 ↗
• MalfunctionOct 18, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED FROM THE SALES REP IN SOUTH AFRICA THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE HAD A POWER CUT IN THE THEATRE ONCE THE UNIT WAS TURNED ON. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17960583 ↗
• MalfunctionOct 16, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE ON (B)(6) 2023 THE 4580 FMS DUO+ PUMP/SHAVER DEVICE EXPERIENCED AN OUTFLOW MECHANISM ISSUE. NEW PUMP WAS USED TO COMPLETE PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17944023 ↗
• MalfunctionOct 12, 2023Use of Device Problem; Improper Flow or Infusion; Use of Device Problem; Improper Flow or Infusion

  IT WAS REPORTED BY THE SALES REP IN HUNGARY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE 4580 FMS DUO+ PUMP/SHAVER DEVICE DID NOT WORK, HAD NO PRESSURE. 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 17920480 ↗
• MalfunctionOct 11, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM THE AFFILIATE IN ITALY THAT THE 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DEVICE HAD A LOCKED PUMP. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 17916038 ↗

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