FreedomEdgeTM F10020Recalls & reported problems

Repro Med Systems, Inc. · Mechanical Syringe Infusion Pump · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00659443000018), received between Mar 31, 2020 and Mar 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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 18, 2026.

Most reported problems

Device problems

Infusion or Flow Problem1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 31, 2020Infusion or Flow Problem
THE CUSTOMER REPORTED A PATIENT WAS ABLE TO START AN INFUSION OMMITTING THE USE OF FLOW RATE TUBING AND DIRECTLY CONNECTING THE NEEDLE SET TO THE SYRINGE WHILE UTILIZING THE FREEDOMEDGE SYRINGE DRIVER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9905477 ↗

Device details

UDI-DI	`00659443000018`
Brand	FreedomEdgeTM
Model	F10020
Company	Repro Med Systems, Inc.
Product code	PKP · Immunoglobulin G (IgG) Infusion System
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Elastomeric infusion pump system filling device

A device that is used to fill an elastomeric infusion pump system chamber with a prescribed medicated solution, to create the pressure required to expand the elastic chamber and the subsequent force that infuses the solution into the patient/user when connected. The device typically holds a syringe prefilled with the solution, and has a handle or lever that is used to push the syringe plunger inward to force the solution into the elastomeric chamber. This device is typically designed for use by a layperson. This is a reusable device.

Other Immunoglobulin G (IgG) Infusion System devices

FREEDOM60® F10050
Repro Med Systems, Inc. · Immunoglobulin G (IgG) Infusion System
58 reports

All Immunoglobulin G (IgG) Infusion System devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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