CADD 21-2120-0105-231Recalls & 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.

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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517150568), received between Sep 10, 2019 and Jun 7, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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

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-2421-2024 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗

Most reported problems

Device problems

Connection Problem1
Device Alarm System1
Infusion or Flow Problem1
Product Quality Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions3
No Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 7, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE DEVICE "SHOWS BOLUS DEVICE REMOVED, ALTHOUGH CONNECTED, DURING BOLUS ADMINISTRATION." THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED. THE PATIENT ONLY ADMINISTERED BOLUSES TO HIMSELF, WHICH WAS NOT POSSIBLE BECAUSE THE DEVICE DID NOT RECOGNIZE THE BOLUS GENERATOR UPON FIRST USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19491682 ↗
MalfunctionJun 6, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT UPON TURNING ON, THE PUMP GAVE ERROR MESSAGE - CODE: 45639 ON THE DISPLAY THAT TURNED RED. THE PUMP WAS NOT OPERATIONAL FOR THIS REASON AND WAS NOT USED. THE PATIENT WAS NOT HARMED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480712 ↗
MalfunctionApr 21, 2023Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE CADD PUMP AIR IN LINE DETECTOR WAS BAD AND NEEDED TO BE REPLACED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16791462 ↗
MalfunctionSep 10, 2019Infusion or Flow Problem; Infusion or Flow Problem
INFORMATION WAS RECEIVED INDICATING THAT INTERNAL SYSTEM DELIVERY ACCURACY TESTING, AN ANOMALY WAS NOTED ON A SMITHS MEDICAL CADD SOLIS VIP PUMP. THE REPORTER INDICATED THAT AN ANOMALY WAS OBSERVED OF SYSTEM DELIVERY BEYOND THE TEST POPULATION, THE AIR IN LINE DETECTOR (AILD) WAS FOUND TO BE LOOSE, BUT ALSO PROTRUDING FURTHER FROM THE CHASSIS OF THE PUMP THAN ALLOWED BY THE GAUGE USED. IN ADDITION, DURING THIS TESTING, SHIM STUDY SHOWED THAT THE DISTANCE THE AILD STICKS OUT IMPACTED SYSTEM DELIVERY ACCURACY. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 8981106 ↗

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-1682-2025 · Apr 10, 2025 · Open, Classified
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP
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-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	`15019517150568`
Brand	CADD
Model	21-2120-0105-231
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 23, 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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2 deaths8,231 reports

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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