CADD 21-2165-64Recalls & reported problems

All models of CADD (123)

Data updated Oct 16, 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 10610586043161), received between Sep 1, 2022 and Sep 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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 16, 2026.

Most reported problems

Device problems

Material Too Rigid or Stiff1
Optical Discoloration1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionSep 1, 2022Material Too Rigid or Stiff; Optical Discoloration; Material Too Rigid or Stiff; Optical Discoloration
IT WAS REPORTED THAT THE DEVICE HAD EXTENSIVE DISCOLORATION OF BAG AND STIFFENING OF MATERIALS, WHICH ARE ABOUT 2 YEARS OLD. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334161 ↗

Device details

UDI-DI	`10610586043161`
Brand	CADD
Model	21-2165-64
Company	Icu Medical, Inc.
Product code	MEA · Pump, infusion, pca
Class	Class 2
FDA submission	K982839
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 Pump, infusion, pca devices

Alaris 8120
Carefusion 303, Inc. · Pump, infusion, pca
2 recalls4 deaths14,640 reports
CADD 21-2111-0402-51
Icu Medical, Inc. · Pump, infusion, pca
4 recalls1,535 reports
CADD 21-2111-0300-01
Icu Medical, Inc. · Pump, infusion, pca
1 recall1,116 reports
Alaris™ PCA Module, Model 8120
Carefusion 303, Inc. · Pump, infusion, pca
2 recalls1 death917 reports
Nimbus II Plus
Infutronix LLC · Pump, Infusion, Pca
1 recall1 death800 reports
CADD 21-2112-0300-01
Icu Medical, Inc. · Pump, infusion, pca
1 recall406 reports
CADD 21-6300-51
Icu Medical, Inc. · Pump, infusion, pca
414 reports
Nimbus II PainPRO
Infutronix LLC · Pump, Infusion, Pca
2 recalls186 reports

All Pump, infusion, pca 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page