Medfusion 22-1000-51Recalls & reported problems

All models of Medfusion (16)

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 10610586031489), received between Dec 9, 2020 and Dec 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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

Mechanical Problem1

Patient problems

No Patient Involvement1

Recent adverse event reports

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

MalfunctionDec 9, 2020Mechanical Problem; Mechanical Problem
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO INJURY TO ANYONE DUE TO THE DEVICE SMOKING EVENT.
Patient problems: No Patient Involvement
MAUDE report 10976571 ↗

Device details

UDI-DI	`10610586031489`
Brand	Medfusion
Model	22-1000-51
Company	Icu Medical, Inc.
Product code	MRZ · ACCESSORIES, PUMP, INFUSION
Class	Class 2
FDA submission	K091181
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 18, 2026

Device type (GMDN): Personal device holder, reusable

A portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, belt or strap intended to pass through the bag’s slots, headband, clothing, or trolley with wheels. This is a reusable device.

Other ACCESSORIES, PUMP, INFUSION devices

Medfusion 4000-0106-01
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls4,390 reports
Medfusion 4000-0105-51
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2 recalls2,882 reports
CADD 21-2111-0401-51
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
4 recalls461 reports
CADD 21-2112-0402-78
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
3 recalls0 reports
MEDFUSION 4000-0106-00
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls10 reports
Medfusion 3500-0600-00
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls9 reports
Medfusion 3500-0600-51
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls2 reports
Medfusion 4000-0105-78
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls0 reports

All ACCESSORIES, PUMP, INFUSION 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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