FMS 281103Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705015764), received between Apr 8, 2020 and Jul 25, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE INTERMEDIARY TUBESET DEVICE TIP WAS ABOUT TO COME OFF. THE TUBING WAS NOT USED IN THE SURGERY AT THE DISCRETION OF THE SURGEON, AND A SUBSTITUTE WAS USED IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607758 ↗
• MalfunctionApr 23, 2025Overfill; Output Problem; Overfill; Output Problem

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON THE SHOULDER JOINT, THE FMS VUE II PUMP-SHAVER BOX DEVICE AND THE INTERMEDIARY TUBESET 24PK DEVICE ACCUMULATED AN EXCESSIVE AMOUNT OF WATER IN THE FILL CHAMBER, CAUSING THE PUMP TO STOP. ALTHOUGH THE INFLOW TUBE WAS REPLACED, THE SAME ISSUE PERSISTED, RENDERING THE DEVICES UNUSABLE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE 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 21891492 ↗
• MalfunctionMar 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, HAIR WAS DISCOVERED INSIDE THE SEALED TRAY OF THE INTERMEDIARY TUBESET 24PK DEVICE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. 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 21645156 ↗
• MalfunctionMay 31, 2022Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT THE BLUE CAP OF THE FMS FLUID MANAGEMENT SYSTEM INTERMEDIARY TUBING WITHOUT ONE-WAY VALVE WAS OFF. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ¿FEMALE VENTED CAP BLUE¿ WAS DETACHED FROM THE TIP ON THE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547549 ↗
• MalfunctionDec 29, 2020Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) TREATING ROTATOR CUFF TEAR ON (B)(6) 2020, IT WAS OBSERVED THAT THE CONNECTING PART OF THE TUBING WAS BROKEN THAT THERE WAS FLUID LEAKING FROM IT. THE BROKEN AREA WAS CUT TO COMPLETE THE PROCEDURE WITH LESS THAN 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089788 ↗
• MalfunctionApr 8, 2020Overfill; Overfill

  IT WAS REPORTED BY AFFILIATE VIA PERSONAL INTERACTION THAT DURING ROTATOR CUFF REPAIR THE INFLOW LIQUID THROUGH THE INFLOW TUBING PASSED OVER THE FILL CHAMBER MARK. AS LOW PRESSURE LAMP BLINKED, THEY TRIED SOME TROUBLESHOOTING SUCH AS DRAINING AND RECONNECTING THE DEVICES CONCERNED, WHICH DID NOT CORRECT THE ISSUE. FINALLY THE INFLOW TUBING AND THE INTERMEDIARY TUBING (281103) WERE REPLACED, WHICH LEAD TO THE COMPLETION OF THE PROCEDURE WITHOUT SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE DEVICES ARE NO LONGER AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9940994 ↗

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-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
• 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