CADD 21-2111-0300-01Recalls & 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 is used to deliver medication. Most of its 1,108 reports describe malfunctions, such as alarm problems, failure to infuse and inaccurate delivery. The reports include no deaths and 2 injuries. Reports fell to 60 in the last 12 months from 268 in the previous 12 months. One open recall, from February 2024, has a software-related root cause.

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: 1,116
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1,116 adverse event reports that list this exact device (DI 10610586038778), received between Feb 26, 2018 and Sep 29, 2026 — classified as 2 injuries, 1,114 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (166 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 System166
Failure to Infuse139
Device Sensing Problem113
Inaccurate Delivery112
Excess Flow or Over-Infusion95
Peeled/Delaminated73
Failure to Sense68
Volume Accuracy Problem67

Patient problems

No Clinical Signs, Symptoms or Conditions870
Insufficient Information187
No Information54
No Patient Involvement38
No Consequences Or Impact To Patient34
No Known Impact Or Consequence To Patient7
Pain4
Dysgeusia1

Recent adverse event reports

The 25 most recent of 1,116 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 29, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940043 ↗
MalfunctionSep 23, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875208 ↗
MalfunctionSep 21, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846233 ↗
MalfunctionSep 16, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792960 ↗
MalfunctionSep 11, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741085 ↗
MalfunctionSep 9, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699371 ↗
MalfunctionSep 8, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677038 ↗
MalfunctionSep 2, 2026Failure to Infuse
It was reported that the pump displayed a System Fault 46,510, with the full fault code reported as 46,510, 303,205,308, 537,652,200, 3,328, 0. This high-priority alarm has the potential to interrupt therapy if it recurs during device use. There was no reported patient involvement, and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564986 ↗
MalfunctionAug 25, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439682 ↗
MalfunctionAug 24, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50420093 ↗
MalfunctionAug 24, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418577 ↗
MalfunctionAug 24, 2026Failure to Infuse
It was reported that during testing the CADD solis HPCA pump had an error code 46508 (UI_ERROR_IRQ_UNDEFINED). There was no patient involvement and harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412629 ↗
MalfunctionAug 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241164 ↗
MalfunctionAug 10, 2026Failure to Infuse
It was reported that when putting the cassette, the pump presents the following message: not attached properly or reattach cassette. Pump alarms only when no cassette is attached, and the latch is closed. This is because the fluid ingress causes sensor drift; DSO counts are higher than the software expects with no cassette attached, and therefore the pump alarms ¿Cassette not attached properly¿. DSO might need calibration. There was no patient involvement or harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192451 ↗
MalfunctionAug 4, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50134105 ↗
MalfunctionJul 15, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825958 ↗
MalfunctionJul 14, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25818585 ↗
MalfunctionJul 9, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769744 ↗
MalfunctionJul 7, 2026Failure to Infuse
THE PUMP GENERATED AN UPSTREAM OCCLUSION ALARM DURING INFUSION. THE CONTENTS WERE REMOVED FROM THE BAG, AND NO TUBING KINKS OR CLOSED CLAMPS WERE FOUND. AN ATTEMPT WAS MADE TO RESTART THE PUMP; HOWEVER, THE DEVICE PROMPTED THE USER TO POWER IT OFF. THE BATTERY DOOR WAS OPENED FOR APPROXIMATELY 10 SECONDS, AND THE PUMP WAS POWERED BACK ON, BUT THE ALARM PERSISTED AND AGAIN INSTRUCTED THE USER TO POWER OFF THE DEVICE. THIS PROCESS WAS REPEATED MULTIPLE TIMES, WITH THE ALARM CONTINUING AND REPEATED REQUESTS TO POWER OFF. SUBSEQUENTLY, THE KEYPAD BECAME LOCKED. THE EVENT OCCURRED IN THE PATIENT'S HOME DURING INFUSION. PATIENT INVOLVEMENT WAS REPORTED; HOWEVER, NO PATIENT HARM RESULTED FROM THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25732984 ↗
MalfunctionJul 3, 2026Failure to Infuse
IT WAS REPORTED THAT PUMP HAS FALSE OCCLUSION WARNINGS AND DOWNSTREAM OCCLUSION. THE EVENT OCCURRED DURING SWITCHED OUT THE PUMP, THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25704956 ↗
MalfunctionJun 29, 2026Failure to Infuse; Material Integrity Problem
IT WAS REPORTED THAT THE CUSTOMER REPEATEDLY RECEIVED A "CASSETTE NOT LATCHED" MESSAGE DESPITE TRYING NEW CASSETTES. THE DETECTOR PINS WERE OBSERVED TO MOVE FREELY. THE CUSTOMER ALSO NOTED APPARENT CRACKING OF THE BLACK RUBBER COMPONENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25655298 ↗
MalfunctionJun 9, 2026Failure to Infuse
IT WAS REPORTED THAT THE DEVICE HAD FAILED AIR IN LINE SENSOR ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25449302 ↗
MalfunctionJun 3, 2026Failure to Sense
IT WAS REPORTED THAT THE PUMP RANDOMLY SHUT OFF AND WENT INTO MANUAL MODE DURING TESTING. DURING INVESTIGATION FOUND THE DAMAGED AIR DETECTOR WHICH NEEDED REPLACEMENT. THIS MALFUNCTION MAKES THE EVENT REPORTABLE. THERE ARE NO PATIENT INVOLVEMENT AND ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382292 ↗
MalfunctionMay 27, 2026Material Integrity Problem; Intermittent Communication Failure
IT WAS REPORTED THAT THE CADD PUMP DISPLAYED A COMMUNICATION MODULE ERROR DURING SELF-TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299717 ↗
MalfunctionMay 26, 2026Intermittent Communication Failure
IT WAS REPORTED THAT THE DEVICE DISPLAYED A COMMUNICATION MODULE ERROR DURING SELF-TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285112 ↗

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	`10610586038778`
Brand	CADD
Model	21-2111-0300-01
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.

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
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
CADD 21-2111-0402-51L
Icu Medical, Inc. · Pump, infusion, pca
3 recalls127 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.

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