FMS 281142Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10886705015900), received between Apr 23, 2018 and Oct 24, 2025 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Defective Device” (25 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 38 reports, in the reporter's own words as published by the FDA.

• 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, 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. THE INFLOW TUBING FMS VUE 24PK DEVICE, INTERMED TUBESET SCHKVLVE 24PK DEVICE AND THE UNK - FLUID MANAGEMENT DEVICE WERE ALL IN USE WITH THE EVENT OCCURRED. 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 2 OF 3 OF (B)(4).

  Patient problems: Extravasation

  MAUDE report 23383245 ↗
• MalfunctionFeb 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE FACILITY DISCOVERED A HAIR IN THE STERILE PACKAGING OF THE INTERMED TUBESET SCHKVLVE 24PK TUBING BEFORE IT WAS OPENED. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 21376278 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 5 OF 5 FOR: (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF FIVE (5) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18849300 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF FIVE (5) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18849115 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF FIVE (5) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18849059 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF FIVE (5) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848940 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 7 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848776 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF FIVE (5) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848765 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 10 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848613 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 9 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848531 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 8 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848503 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 6 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848406 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 5 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848300 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 4 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848273 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 3 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848237 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 2 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848213 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 1 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18848134 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 10 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18847286 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 9 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18847140 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 8 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18847102 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 7 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18847015 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 6 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18846917 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 5 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18846867 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 4 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18846828 ↗
• MalfunctionMar 6, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  THIS IS REPORT 3 OF 10 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT FLUID WAS BACKING UP INTO THE PUMPS OF TEN (10) INTERMED TUBESET SCHKVLVE 24PK DEVICES AND CAUSING THE PUMPS TO FAIL. IT WAS NOT REPORTED IF THE DEVICES WERE USED IN SURGERY, OR IF THERE WAS 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 18846791 ↗

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