FMS 284172Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705017249), received between Jun 22, 2020 and Oct 25, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE AFFILIATE IN SWEDEN THAT DURING THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE 4172 FOOT PED BOARD 2WAY DEVICE HAD INCORRECT LABELING. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003649 ↗
• MalfunctionMar 19, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE 4172 FOOT PED BOARD 2 WAY HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE FOOTSWITCH ON THE PEDAL 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 13826663 ↗
• MalfunctionJun 24, 2021Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4172 FOOT PED BOARD 2WAY DEVICE WOULD DISENGAGE AND ITS PLASTIC COVERS WERE BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE PEDAL MECHANISMS AND THE COVER WERE BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059142 ↗
• MalfunctionJun 22, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT AFTER AN UNKNOWN PROCEDURE WHILE SETTING UP THE FMS DUO PUMP THE SCREW OF THE PLUG OF THE 2 WAY FOOT PEDAL FOR FMS DUO+ BROKE OFF INSIDE THE PUMP AND IT IS STUCK. ADDITIONAL DEVICES WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. BOTH DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10182339 ↗

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