CADD 21-2112-0300-00Recalls & reported problems

All models of CADD (123)

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

4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 4

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10610586038822), received between Apr 26, 2024 and Nov 25, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

4 FDA recall records name this device's identifier, 4 still open.

1 other recall cover devices cleared under the same FDA submission (K130394); 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Apr 10, 2025Class IOpen, Classified
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Z-1662-2025 · Root cause: Software design · Recall details · FDA record ↗
Apr 10, 2025Class IOpen, Classified
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Z-1681-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Apr 10, 2025Class IOpen, Classified
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Z-1667-2025 · Root cause: Labeling design · Recall details · FDA record ↗
Apr 10, 2025Class IOpen, Classified
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Z-1668-2025 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Device problems

Device Alarm System2
Failure to Sense2
Blocked Connection1
Device Sensing Problem1
Material Integrity Problem1
Priming Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions4
Insufficient Information2

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 25, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED, THAT WHEN TRYING TO RUN THE TESTS. THE DEVICE WOULD NOT RECOGNISE THE CASSETTE BEING LOCKED. PUMP WILL NOT RUN WITHOUT CASSETTE BEING LOCKED. THERE WAS UNKNOWN, PATIENT INVOLVEMENT. AND UNKNOWN, PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20771922 ↗
MalfunctionSep 13, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE AIR DETECTOR WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20212183 ↗
MalfunctionJul 10, 2024Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE WAS FOR SERVICE REPAIR. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. ANALYSIS IDENTIFIED AN UPSTREAM OCCLUSION SENSOR ALARM WAS MALFUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19711248 ↗
MalfunctionJun 24, 2024Device Alarm System; Priming Problem; Device Alarm System; Priming Problem
IT WAS REPORTED THAT THE DEVICE PRODUCED A PROBLEM WHEN PRIMING WITH WATER. THE DEVICE ALSO EXHIBITED AN UPSTREAM PRESSURE ALARM. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 19594734 ↗
MalfunctionJun 19, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE DOWNSTREAM OCCLUSION SENSOR RUBBER WAS DAMAGED. THERE WAS UNKNOWN PATIENT INVOLVEMENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19566443 ↗
MalfunctionApr 26, 2024Device Alarm System; Blocked Connection; Device Alarm System; Blocked Connection
IT WAS REPORTED THAT THE DEVICE HAD AN "OCCLUSION ALARM ". THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19198057 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130394. One submission often covers many models, so check the product and lot details in each record.

Z-1813-2015 · May 26, 2015 · Terminated
CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospita

Device details

UDI-DI	`10610586038822`
Brand	CADD
Model	21-2112-0300-00
Company	Icu Medical, Inc.
Product code	MEA · Pump, infusion, pca
Class	Class 2
FDA submission	K130394
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	Apr 16, 2025

Device type (GMDN): Bedside infusion pump, single-channel

An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 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