FMS SOLO 284590Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 10886705020614), received between Feb 23, 2018 and May 16, 2025 — classified as 112 malfunctions.

The most frequently reported specific device problem is “Overfill” (36 reports).

1 other recall cover devices cleared under the same FDA submission (K002040); 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 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHEN RUNNING THE 4590 FMS SOLO IRRIGATION PUMP -NS DEVICE IT WAS SUPPOSED TO GET TO 50 ON THE GAUGE BUT, IT WOULD ONLY REACH AROUND 29-30. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN 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 22038928 ↗
• MalfunctionOct 2, 2024Increase in Pressure; Improper Flow or Infusion; Output Problem; Increase in Pressure; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4590 FMS SOLO IRRIGATION PUMP HAD PRESSURE ERRORS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351178 ↗
• MalfunctionMay 20, 2024Overfill; Overfill

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT AND KNEE SCOPE SURGICAL PROCEDURE, IT WAS DISCOVERED THAT 4590 FMS SOLO IRRIGATION PUMP -NS DEVICE X 2 CHAMBERS WERE NOT FILLING UP WITH WATER. IT WAS REPORTED THAT THE TUBE WAS CHANGED OUT IN ORDER TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED DELAY TO THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349876 ↗
• MalfunctionMay 20, 2024Overfill; Overfill

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT AND KNEE SCOPE SURGICAL PROCEDURE, IT WAS DISCOVERED THAT 4590 FMS SOLO IRRIGATION PUMP -NS DEVICE X 2 CHAMBERS WERE NOT FILLING UP WITH WATER. IT WAS REPORTED THAT THE TUBE WAS CHANGED OUT IN ORDER TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED DELAY TO THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349875 ↗
• MalfunctionMay 7, 2024Improper Flow or Infusion; Output Problem; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE FMS SOLO IRRIGATION PUMP DEVICE HAD A LOW PRESSURE ALARM. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 19261191 ↗
• MalfunctionMay 3, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE 4590 FMS SOLO IRRIGATION PUMP -NS DEVICE LOST PRESSURE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 19242939 ↗
• MalfunctionMar 12, 2024Increase in Pressure; Output Problem; Increase in Pressure; Output Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE 4590 FMS SOLO IRRIGATION PUMP DEVICE WAS NOT HOLDING PRESSURE AND WAS ERRATIC. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THE SAME DEVICE. 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 18890572 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT ON AN UNKNOWN DATE IT WAS REPORTED THAT THE 4590 FMS SOLO IRRIGATION PUMP DEVICE STOPPED WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WOULD NOT RUN DUE TO MOTOR DAMAGE. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370825 ↗
• MalfunctionDec 19, 2023Break; Break

  DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE 4590 FMS SOLO IRRIGATION PUMP DEVICE FRACTURED. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357752 ↗
• MalfunctionDec 6, 2023Improper Flow or Infusion; Improper Flow or Infusion

  REPORT 2 OF 2 FOR (B)(4): IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE PRESSURE ON THE 4590 FMS SOLO IRRIGATION PUMP DEVICE WAS LOW WITH DIFFERENT TUBING USED. 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 18273691 ↗
• MalfunctionDec 6, 2023Improper Flow or Infusion; Improper Flow or Infusion

  REPORT 1 OF 2 FOR (B)(4): IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE PRESSURE ON THE 4590 FMS SOLO IRRIGATION PUMP DEVICE WAS LOW WITH DIFFERENT TUBING USED. 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 18273676 ↗
• MalfunctionNov 30, 2023Overfill; Overfill

  IT WAS REPORTED BY THE SALES REP THAT PRIOR TO A SURGICAL PROCEDURE ON11/2/2023 THE4590 FMS SOLO IRRIGATION PUMP -NS DEVICE MALFUNCTIONED. IT WAS FILLING UP THE RESERVOIR TO THE TOP AND SPIN WHEEL KEEP SPINNING AND WAS FILLING THE TUBBING MAKING THE PUMP INOPERABLE. ANOTHER PUMP USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238968 ↗
• MalfunctionMar 20, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4590 FMS SOLO IRRIGATION PUMP DEVICE HAD LOW PRESSURE. THE SAME 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 16575666 ↗
• MalfunctionJan 23, 2023Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE 4590 FMS SOLO IRRIGATION PUMP DEVICE WAS NOT HAVING ANY PRESSURE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225769 ↗
• MalfunctionNov 2, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4590 FMS SOLO IRRIGATION PUMP DEVICE HAD EXCESSIVE FLOW. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716956 ↗
• MalfunctionOct 26, 2022Overfill; Overfill

  IT WAS REPORTED BY A SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4590 FMS SOLO IRRIGATION PUMP DEVICE KEPT FILLING UP ALL THE WAY BUT SEEMED TO BE HOLDING PRESSURE. ACCORDING TO THE REPORT, WHEN THE PUMP GOT FULL, IT WOULD AFFECT THE SENSOR. 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 15673889 ↗
• MalfunctionJun 30, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE DOOR AROUND THE WHEEL HINGE ON THE 4590 FMS SOLO IRRIGATION PUMP DEVICE WAS BROKEN WHICH CAUSING THE PUMP TO INTERNALLY SHUT DOWN. 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 14876229 ↗
• MalfunctionJan 26, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THROUGH IN-HOUSE INSPECTION OF RETURNED CAPITAL EQUIPMENT THAT THE DOOR ON THE 4590 FMS SOLO IRRIGATION PUMP DEVICE WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A BROKEN DOOR. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359760 ↗
• MalfunctionJan 26, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THROUGH IN-HOUSE INSPECTION OF RETURNED CAPITAL EQUIPMENT THAT THE DOOR ON THE 4590 FMS SOLO IRRIGATION PUMP WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A BROKEN DOOR. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359715 ↗
• MalfunctionJan 14, 2022Break; Break

  IT WAS REPORTED THAT THE DOOR ON THE 4590 FMS SOLO IRRIGATION PUMP WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258621 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE 4590 FMS SOLO IRRIGATION PUMP DEVICE HAD AN UNSPECIFIED COMPONENT DAMAGE. DURING IN-HOUSE SERVICE AND REPAIR EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A BROKEN FACE COVER PLATE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975235 ↗
• MalfunctionDec 2, 2021Increase in Pressure; Overfill; Increase in Pressure; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PRESSURE ON THE 4590 FMS SOLO IRRIGATION PUMP DEVICE WAS INCREASING AND THE CHAMBER KEPT FILLING UP. 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 12915684 ↗
• MalfunctionDec 1, 2021Increase in Pressure; Overfill; Increase in Pressure; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PRESSURE ON THE 4590 FMS SOLO IRRIGATION PUMP DEVICE WAS INCREASING AND THE CHAMBER KEPT FILLING UP. 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 12911445 ↗
• MalfunctionDec 1, 2021Increase in Pressure; Overfill; Increase in Pressure; Overfill

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PRESSURE ON THE 4590 FMS SOLO IRRIGATION PUMP DEVICE WAS INCREASING AND AND THE CHAMBER KEPT FILLING UP. 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 12911416 ↗
• MalfunctionOct 29, 2021Overfill; Improper Flow or Infusion; Output Problem; Overfill; Improper Flow or Infusion; Output Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4590 FMS SOLO IRRIGATION PUMP DEVICE HAD LOW PRESSURE THAT THE FILL CHAMBER WAS FILLING ALL THE WAY UP BUT IT WOULD STOP AND KEEP BEEPING. IT WAS REPORTED THAT THE DEVICE WAS TURNED OFF, RESTARTED THEN ALSO CHANGED THE TUBING BUT IT WAS STILL DOING THE SAME THING. 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 12721209 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002040. One submission often covers many models, so check the product and lot details in each record.

• 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