CADD 21-2112-0300-01Recalls & reported problems

All models of CADD (123)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This ICU Medical CADD infusion pump delivers medication through a line. Its 403 adverse event reports most often describe alarms that did not sound, pumps that failed volume accuracy tests, and delivery problems. Reports list 4 injuries and no deaths. There is 1 open recall, started in February 2024, with a listed cause in software manufacturing, and reports fell from 74 in the prior 12 months to 26 in the last 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 406
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 406 adverse event reports that list this exact device (DI 10610586038808), received between Jan 8, 2018 and Sep 22, 2026 — classified as 4 injuries, 402 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (83 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls 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

Feb 27, 2024Class IOpen, Classified
The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
Z-2420-2024 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗

Most reported problems

Device problems

Device Alarm System83
Volume Accuracy Problem48
Inaccurate Delivery44
Excess Flow or Over-Infusion43
Device Sensing Problem42
Failure to Infuse37
Failure to Sense32
Insufficient Flow or Under Infusion30

Patient problems

No Clinical Signs, Symptoms or Conditions279
Insufficient Information78
No Information35
No Patient Involvement35
No Known Impact Or Consequence To Patient8
No Consequences Or Impact To Patient7
Overdose2
Discomfort1

Recent adverse event reports

The 25 most recent of 406 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 22, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857882 ↗
MalfunctionSep 15, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780296 ↗
MalfunctionSep 11, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744156 ↗
MalfunctionJul 2, 2026Device Alarm System; No Flow
IT WAS REPORTED THAT THE CADD PUMP SHOULD HAVE GENERATED AN ALARM, BUT NO ALARM OCCURRED WHEN THERE WAS NO FLUID IN THE LINE. THE MEDICATION BAG WAS NOT FULLY INSERTED INTO THE EPIDURAL ADMINISTRATION SET SPIKE. THE FACILITY HAS THE CADD EPIDURAL PUMP INVOLVED IN THE EVENT AND OBTAINED ANOTHER UNIT ON WHICH THE NURSE, IN COLLABORATION WITH THE ANESTHESIOLOGY DEPARTMENT, WAS ABLE TO REPRODUCE THE ISSUE. DURING THE PROCEDURE, DESPITE THE MEDICATION BAG BEING ONLY MINIMALLY ENGAGED WITH THE SPIKE, THE PUMP CONTINUED OPERATING AS THOUGH FLUID WAS FLOWING THROUGH THE LINE. NO AIR-IN-LINE ALARM OR ERROR WAS GENERATED AT ANY POINT. THERE WAS NO PATIENT INVOLVEMENT DURING THE TESTING, AND NO HARM WAS REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25693468 ↗
InjuryJul 2, 2026No Flow
IT WAS REPORTED THAT THE CADD PUMP SHOULD HAVE ALARMED, BUT IT DID NOT ALARM WHEN THERE WAS NO FLUID IN THE LINE. THE MEDICATION BAG WAS NOT FULLY SPIKED INTO THE EPIDURAL ADMINISTRATION SET. ONE CADD EPIDURAL PUMP WAS INVOLVED IN THE PATIENT EVENT, AND ANOTHER UNIT WAS OBTAINED FOR TESTING. THE NURSE, ALONG WITH THE ANESTHESIOLOGY DEPARTMENT, WAS ABLE TO DUPLICATE THE ORIGINAL PROBLEM USING THE SECOND UNIT. DURING THE PROCEDURE, DESPITE THE BAG BEING ONLY PARTIALLY SPIKED, THE UNIT CONTINUED TO PUMP AS IF FLUID WAS FLOWING THROUGH THE LINE. THE AIR-IN-LINE ALARM DID NOT OCCUR. DUE TO THE DEVICE NOT ALARMING, THE PATIENT WAS RUSHED INTO EMERGENCY SURGERY TO PREVENT FURTHER PAIN. THE NURSE WHO WAS PRESENT DURING THE PROCEDURE WAS ABLE TO REPRODUCE THE ISSUE USING THE SAME EPIDURAL SETUP. THERE WAS PATIENT INVOLVEMENT, AND THE EVENT RESULTED IN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25691315 ↗
MalfunctionMay 26, 2026Device Sensing Problem; Air/Gas in Device
IT WAS REPORTED DURING INFUSION THAT THE PATIENT HAD AN EPIDURAL, UPON INSPECTION THE MED BAG WAS NOT PROPERLY SPIKED, AND PATIENT MAY HAVE BEEN RECEIVING AIR. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25277255 ↗
MalfunctionMay 18, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP FAILED VOLUMETRIC ACCURACY TEST AT 7.5% ACCURACY ERROR AND IT WAS FOUND OUT DURING NOT IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203014 ↗
MalfunctionMay 12, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE PUMP HAD A FAILED VOLUMETRIC ACCURACY. THERE WAS NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25152896 ↗
MalfunctionMay 11, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE PUMP FAILED VOLUMETRIC ACCURACY TEST AT (B)(4) ACCURACY ERROR. THERE WAS NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137454 ↗
MalfunctionMay 7, 2026Volume Accuracy Problem
IT WAS REPORTED THAT DURING ROUTINE PREVENTIVE MAINTENANCE INSPECTION THE UNIT FAILED THE ACCURACY TEST AND ADMINISTERED AN AMOUNT OVER THE UPPER ALLOWABLE LIMIT. INVESTIGATION CONFIRMED THE MALFUNCTION THROUGH FUNCTIONAL TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111591 ↗
MalfunctionMay 1, 2026Device Sensing Problem
IT WAS REPORTED THAT THE EPIDURAL PUMP CONTINUOUSLY DISPLAYED A ¿CASSETTE NOT LOCKED¿ ERROR DESPITE PROPER CASSETTE INSTALLATION BEFORE INFUSION. TROUBLESHOOTING WAS ATTEMPTED MULTIPLE TIMES AND ULTIMATELY REPLACED THE PUMP. THE SAME CASSETTE FUNCTIONED NORMALLY IN THE REPLACEMENT PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059890 ↗
MalfunctionApr 30, 2026Crack
THE DEVICE EVALUATION NOTED A CRACKED DOWNSTREAM OCCLUSION SEAL. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE. THERE WERE NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049953 ↗
MalfunctionApr 30, 2026Crack
THE DEVICE EVALUATION NOTED A CRACK DOWNSTREAM OCCLUSION SEAL. IT OCCURRED DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048255 ↗
MalfunctionApr 30, 2026Crack
THE DEVICE EVALUATION NOTED A TORN AND CRACKED DOWNSTREAM OCCLUSION SEAL. IT OCCURRED DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048214 ↗
MalfunctionApr 20, 2026Device Sensing Problem
IT WAS REPORTED THAT DURING TESTING THE CADD-SOLIS WAS UNDER INFUSING. THERE WAS NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926207 ↗
MalfunctionApr 9, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP IS GIVING A 41786 ERROR CODE WHEN CUSTOMER TURN IT ON, HE TRIED WITHOUT BATTERIES AND JUST POWER SUPPLY AND TRIED ON BATTERY POWER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834622 ↗
MalfunctionApr 6, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP HAD A RED ERROR SCREEN AT STARTUP "41786" ACROSS "0004". THE EVENT OCCURRED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790694 ↗
MalfunctionApr 3, 2026Failure to Infuse
IT WAS REPORTED THAT THE ERROR IN LINE ALARM AFTER SEVERAL PRIMES. FOUND DURING STARTUP. NO DELAY IN THERAPY OCCURRED. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778975 ↗
MalfunctionMar 17, 2026Failure to Infuse
IT WAS REPORTED THAT THE DEVICE WAS FOUND WITH ERROR CODE 46446. THE DEVICE IS CURRENTLY END OF LIFE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621797 ↗
MalfunctionFeb 25, 2026Complete Blockage
IT WAS REPORTED THAT A DOWNSTREAM OCCLUSION OCCURRED. THE DEVICE ASKED TO DO A FIRMWARE UPDATE, BUT DRUG LIBRARY DID NOT DOWNLOAD. THE EVENT OCCURRED DURING SET-UP. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24446001 ↗
MalfunctionFeb 12, 2026Degraded
THE DEVICE WAS RETURNED AS IT WAS REPORTED THAT WHEN THE PUMP WAS PLUGGED IN, THE CHARGING PORT FAILED TO RECOGNIZE THE AC ADAPTER. THE RESULTS OF THE INVESTIGATION FOUND THAT THE DEVICE'S UPSTREAM OCCLUSION (USO) SEAL WAS BUCKLED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327125 ↗
MalfunctionFeb 5, 2026Degraded
IT WAS REPORTED THAT THE DSO SEAL HAD BEEN DELAMINATED, AND IT HAD OCCURRED DURING SETUP. THERE WERE NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272157 ↗
MalfunctionJan 29, 2026Crack
THE CUSTOMER RETURNED THE DEVICE FOR NOT TURNING ON. DURING DEVICE EVALUATION, A CRACKED DOWNSTREAM OCCLUSION SEAL (DSO) WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209341 ↗
MalfunctionJan 28, 2026Degraded; Failure to Sense
THE DEVICE WAS RETURNED DUE TO CASSETTE SENSOR ISSUE. UPON PHYSICAL INSPECTION, A DEFECTIVE DOWNSTREAM OCCLUSION (DSO) SENSOR. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202276 ↗
MalfunctionJan 19, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP EXHIBITED 41622 ERROR CODE/ALARMING. THE STATUS OF THE PRODUCT AT TIME OF EVENT WAS DURING TESTING. THE END-OF-LIFE (EOL) DEVICE WILL NOT BE SCHEDULED FOR SERVICE OR EVALUATION, AS IT HAS REACHED ITS END-OF-LIFE STATUS. WE ARE ENSURING THAT THE COMPLAINT IS DOCUMENTED APPROPRIATELY FOR GCM RECORDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111853 ↗

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-1667-2025 · Apr 10, 2025 · Open, Classified
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SO
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	`10610586038808`
Brand	CADD
Model	21-2112-0300-01
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.

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Nimbus II PainPRO
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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.

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