FMS 281113Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705015856), received between Dec 20, 2017 and Aug 27, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S 1113 GRAVITY TUBE SET WAS LEAKING WHERE THE BULB AND TUBE CONNECT PRIOR TO A SHOULDER SCOPE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7816662 ↗
• MalfunctionMar 23, 2018Pressure Problem; Increase in Pressure; Device Displays Incorrect Message; Pressure Problem

  WHEN FILLING THE PRESSURE CHAMBER FMS VUE 2 DID NOT STOP. PRESSURE INCREASED UNTIL HIGH PRESSURE ALARM WAS CAUSED. SALES REP TESTED TUBE SYSTEM WITH DIFFERENT FMS PUMP AND IT WORKED FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7366279 ↗
• MalfunctionDec 20, 2017Filling Problem; Overfill; Filling Problem; Overfill

  FILL CHAMBER OVERFILLED KNEE SCOPE. NO DELAY. NO PATIENT HARM. USED ANOTHER UNIT TO COMPLETE THE SURGERY. NEW UNIT TO (B)(6) IN BIOMED. ADDITIONAL INFORMATION RECEIVED ON 2/15/2018: THERE WAS NO VISIBLE LOT NUMBER ON THE DEVICE DUE TO ITS AGE, ALSO THE DEVICE WAS DISCARDED BY THE ACCOUNT AND WILL NOT BE COMING BACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133068 ↗

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