CADD 21-2120-0102-78Recalls & 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-Solis infusion pump delivers IV fluids and medication. The 32 reports mostly describe the pump failing to run or sense properly — failing to infuse, not detecting a cassette or blockage, unexpected error codes and alarms during testing, plus a peeling outer surface and contamination. No deaths and no injuries are described. One open recall, started in April 2025, covers a potential for heat (thermal) damage to the pump. Reports have dropped from 12 in the earlier 12 months to 5 in the most recent.

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: 33
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10610586042836), received between Nov 7, 2018 and Sep 11, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (10 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K111275); 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
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Z-1682-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Failure to Infuse10
Device Sensing Problem8
Device Alarm System4
Contamination3
Failure to Sense3
Peeled/Delaminated3
Circuit Failure2
Key or Button Unresponsive/not Working2

Patient problems

No Clinical Signs, Symptoms or Conditions29
Insufficient Information3
No Consequences Or Impact To Patient1

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 11, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740958 ↗
MalfunctionAug 26, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50461548 ↗
MalfunctionMar 25, 2026Peeled/Delaminated; Failure to Sense; Failure to Infuse; Device Sensing Problem
IT WAS REPORTED THAT THE PUMP HAD AN EVENT OF CASSETTE DID NOT ATTACH PROPERLY. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688487 ↗
MalfunctionMar 4, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP HAD AN EVENT OF CASSETTE NOT ATTACHED DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512185 ↗
MalfunctionFeb 9, 2026Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE PUMP HAD AN OVER INFUSION. THE EVENT OCCURRED DURING PRE-TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24299132 ↗
MalfunctionNov 17, 2025Device Sensing Problem; Device Sensing Problem
THE DEVICE EVOLUTION IDENTIFIED DAMAGED DOWNSTREAM OCCLUSION SENSOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569325 ↗
MalfunctionSep 17, 2025Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT PUMP HAD CONTINUOUS BEEPING AND ERROR CODE 41100. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073380 ↗
MalfunctionSep 17, 2025Contamination; Degraded; Failure to Infuse; Contamination; Degraded; Failure to Infuse
IT WAS REPORTED THAT THE PUMP HAD CASSETTE ERROR AND ERROR CODE 46228 (UNEXPECTED MICROPROCESSOR RESET) DURING TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073370 ↗
MalfunctionAug 13, 2025Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 46822, WHICH IS A SYSTEM FAULT THAT INDICATES A MALFUNCTION OF THE PUMP'S INTERNAL COMPONENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797845 ↗
MalfunctionMay 27, 2025Contamination; Failure to Sense; Contamination; Failure to Sense
IT WAS REPORTED THAT A CASSETTE ATTACHMENT ERROR OCCURRED AS SOON AS THE CASSETTE WAS ATTACHED TO THE PUMP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089309 ↗
MalfunctionMay 27, 2025Failure to Infuse; Key or Button Unresponsive/not Working; Failure to Infuse; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE PUMP'S BUTTONS WERE NOT WORKING, THERE WAS A ''KEY STUCK'' ALARM, AND HAD AN ERROR CODE 46822. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089115 ↗
MalfunctionFeb 25, 2025Obstruction of Flow; Device Sensing Problem; Obstruction of Flow; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE EXHIBITED A DOWNSTREAM OCCLUSION ALARM AFTER THE TUBE OCCLUSION WAS REMOVED. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21459611 ↗
MalfunctionFeb 21, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THERE WAS AN OCCLUSION. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432732 ↗
MalfunctionJan 6, 2025Peeled/Delaminated; Peeled/Delaminated
THE RESULTS OF THE INVESTIGATION FOUND THAT THE DEVICE HAD A DELAMINATED DOWNSTREAM OCCLUSION (DSO) SEAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079700 ↗
MalfunctionNov 27, 2024Circuit Failure; Failure to Infuse; Circuit Failure; Failure to Infuse
IT WAS REPORTED THAT THE PUMP SHOWED ERROR CODE 41626. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20801270 ↗
MalfunctionNov 26, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT WITH THE DEVICE THERE WAS A KEY STUCK/RELEASE KEY. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20789046 ↗
MalfunctionNov 18, 2024Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE EXHIBITED A CASSETTE DETECT ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20716121 ↗
MalfunctionNov 6, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE AIR DETECTOR IS LOOSE AND COMING OFF. THE ISSUE WAS DISCOVERED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621057 ↗
MalfunctionOct 24, 2024Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE HAD A "CASSETTE NOT ATTACHED" ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20522908 ↗
MalfunctionOct 21, 2024Contamination; Device Sensing Problem; Contamination; Device Sensing Problem
IT WAS REPORTED THAT THE PUMP EXHIBITED A NO DISPOSABLE CASSETTE ISSUE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20494631 ↗
MalfunctionOct 11, 2024False Alarm; False Alarm
IT WAS REPORTED THAT THE DEVICE HAD A DOWNSTREAM OCCLUSION AFTER OCCLUSION WAS REMOVED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20428068 ↗
MalfunctionOct 11, 2024Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE DEVICE HAD A CASSETTE ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427616 ↗
MalfunctionSep 20, 2024Circuit Failure; Device Sensing Problem; Circuit Failure; Device Sensing Problem
DEVICE WAS RETURNED FOR NO DISPOSABLE DETECTED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20265671 ↗
MalfunctionSep 5, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE PUMP EXHIBITED CASSETTE MALFUNCTIONS. THE CUSTOMER RETURNED THE PRODUCT FOR CASSETTE MALFUNCTION, AND DURING INSPECTION IT WAS FOUND THAT THERE WAS INTERMITTENT CASSETTE NOT ATTACHED PROPERLY AND DOWNSTREAM OCCLUSION ALARMS WHEN LATCH CASSETTE USED TO PRIME. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20147392 ↗
MalfunctionAug 9, 2024Defective Component; Device Sensing Problem; Defective Component; Device Sensing Problem
IT WAS REPORTED THAT THE CASSETTE N/A. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19953020 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111275. One submission often covers many models, so check the product and lot details in each record.

Z-1668-2025 · Apr 10, 2025 · Open, Classified
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0
Z-0222-2025 · Jul 16, 2024 · Open, Classified
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-
Z-0466-2025 · Jun 26, 2024 · Open, Classified
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Z-2421-2024 · Feb 27, 2024 · Open, Classified
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proxi
Z-0107-2022 · Mar 24, 2020 · Terminated
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 2

Device details

UDI-DI	`10610586042836`
Brand	CADD
Model	21-2120-0102-78
Company	Icu Medical, Inc.
Product code	FRN · Pump, infusion
Class	Class 2
FDA submission	K111275
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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CADD 21-6500-51
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All 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 · 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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