CADD 21-2111-0400-51Recalls & 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.

Quick summary

This CADD Solis infusion pump is an ambulatory pump used to deliver medication. Some of the 124 reports describe false or missing alarms, cracked seals, and the pump failing to infuse, and most list no clinical signs for the patient. The reports include no deaths and no injuries. There are 4 open recalls, over wireless connection alarms and false occlusion alarms that could interrupt therapy.

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: 124
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 4

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 10610586041037), received between Jul 26, 2018 and Sep 10, 2026 — classified as 124 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (15 reports).

4 FDA recall records name this device's identifier, 4 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
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 ↗
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 ↗
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 System15
Crack12
Device Sensing Problem12
Failure to Infuse12
Detachment of Device or Device Component9
Audible Prompt/Feedback Problem8
Degraded8
Material Split, Cut or Torn8

Patient problems

No Clinical Signs, Symptoms or Conditions101
Insufficient Information20
No Patient Involvement2
No Information1

Recent adverse event reports

The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 10, 2026Failure to Infuse
It was reported that when latch of the device was closed and no cassette attached, alarms "cassette incorrectly attached" during preventive maintenance testing and no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713666 ↗
MalfunctionAug 24, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50420194 ↗
MalfunctionAug 12, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227607 ↗
MalfunctionJun 29, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP DID NOT RECOGNIZE THE CASSETTE, AND THE ISSUE WAS IDENTIFIED DURING ANNUAL SERVICE. DURING THE INVESTIGATION, THE EVENT HISTORY LOG (EHL) SHOWED ALARM MESSAGES STATING, ¿HIGH ALARM DISPLAYED: CASSETTE NOT ATTACHED PROPERLY.¿ THIS MALFUNCTION MAKES THE EVENT REPORTABLE. NO PATIENT HARM OR ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660132 ↗
MalfunctionJun 5, 2026Crack
IT WAS OBSERVED DURING INSPECTION OF A RETURNED CADD PUMP THAT THE DOWNSTREAM OCCLUSION SEAL WAS CRACKED. THIS MAY LEAD TO FLUID INGRESS INTO THE PUMP WHICH WILL INTERRUPT THERAPY DURING INFUSION IF IT RECURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414901 ↗
MalfunctionMay 12, 2026Defective Alarm; Failure to Infuse
IT WAS STATED THAT THE PUMP WAS ALARMING THAT THE CARTRIDGE WAS NOT ENGAGED WHEN ITS LOCKED AND THE CUSTOMER TRIED WITH FEW DIFFERENT CARTRIDGES. THIS IS CLASSIFIED AS A HIGH-PRIORITY ALARM AND INDICATES THAT THE DISPOSABLE CARTRIDGE IMPROPERLY ATTACHED. ALTHOUGH NO PATIENT INVOLVEMENT OR HARM WAS REPORTED, THE CONDITION MAY RECUR DURING PATIENT USE AND HAS THE POTENTIAL TO STOP THE PUMP. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150085 ↗
MalfunctionApr 9, 2026Insufficient Flow or Under Infusion
IT WAS STATED THAT THE PUMP WAS SHOWING THAT THE VOLUME WAS EMPTY BUT THERE WAS A HALF A BAG OF FLUID WAS AVAILABLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830450 ↗
MalfunctionApr 8, 2026Device Sensing Problem
THE CUSTOMER RETURNED THE DEVICE STATING, ¿THE PUMP'S PATIENT-CONTROLLED ANALGESIA PORT FOR THE REMOTE CORD WAS NOT ALIGNED OR WORKING PROPERLY AND IT WAS NOT ABLE TO FULLY INSERT A PATIENT-CONTROLLED ANALGESIA REMOTE INTO THE UNIT, ONLY ABOUT HALFWAY AND IT WOULD FALL OUT OF THE PORT VERY EASILY CAUSING IT TO DISCONNECT¿; DURING DEVICE EVALUATION THE DOWNSTREAM OCCLUSION SENSOR WAS FAULTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817573 ↗
MalfunctionApr 6, 2026Failure to Sense
THE DEVICE WAS RETURNED AS IT WAS STATED THAT THERE WAS AN AIR IN LINE MESSAGE EVEN THOUGH DEVICE WELL PRIMED. THE RESULTS OF THE INVESTIGATION CONFIRMED THAT THE AIR DETECTOR WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792143 ↗
MalfunctionApr 1, 2026Failure to Infuse
IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING ERROR 41622. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752995 ↗
MalfunctionMar 24, 2026Air/Gas in Device
IT WAS REPORTED THAT THE PUMP EXHIBITED AIR IN LINE MESSAGE EVEN THOUGH THE DEVICE WAS WELL PRIMED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680019 ↗
MalfunctionMar 5, 2026Crack
THE CUSTOMER RETURNED THE PRODUCT FOR DAMAGED AIR SENSOR AND THAT IT REQUIRED REPLACEMENT. DURING DEVICE EVALUATION, A CRACKED DOWNSTREAM OCCLUSION (DSO) SEAL WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519884 ↗
MalfunctionFeb 27, 2026Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE HAD FAILED TEST AND CASSETTE SENSORS WERE NOT WORKING PROPERLY. EVENT OCCURRED DURING PREVENTIVE MAINTENANCE TESTING AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24476191 ↗
MalfunctionFeb 27, 2026Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE DEVICE HAD DELIVERED BOLUS VOLUME TOO HIGH, REQUIRED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471454 ↗
MalfunctionFeb 11, 2026Failure to Infuse
IT WAS REPORTED THAT THE DEVICE TURNED ON WITH RED SCREEN AND WAS DISPLAYING ERROR CODE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313661 ↗
MalfunctionFeb 11, 2026False Alarm
IT WAS REPORTED THAT THE PUMP WAS REPEATEDLY SHOWING AN OCCLUSION ERROR EVEN THOUGH THERE WAS NO ACTUAL OCCLUSION PRESENT. DESPITE CHECKING THE TUBING, CASSETTE AND SETUP, THE ERROR CONTINUED TO OCCUR FREQUENTLY. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313279 ↗
MalfunctionFeb 10, 2026Defective Component
IT WAS STATED THAT THE CASSETTES WERE NOT ATTACHING ON ANY CASSETTE AND THE ERROR ALSO OCCURRED WHEN NO CASSETTE WAS ATTACHED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304368 ↗
MalfunctionFeb 10, 2026Crack
THE CUSTOMER WAS REPORTED THAT THE DEVICE HAD ALARMS OR SOUNDS WERE NOT LOUD ENOUGH. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE IDENTIFIES THE CRACK ON DOWNSTREAM OCCLUSION (DSO) SEAL. THIS LED TO INTERRUPTION OF THERAPY WHILE IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304327 ↗
MalfunctionFeb 6, 2026Device Sensing Problem
THE DEVICE EVALUATION IDENTIFIED DSO SEAL PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280055 ↗
MalfunctionFeb 4, 2026Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE WAS ALARMING "CASSETTE NOT ATTACHED PROPERLY. REATTACH CASSETTE". THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE DEVICE EVALUATION NOTED A FAULTY DOWNSTREAM OCCLUSION SENSOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257968 ↗
MalfunctionJan 13, 2026Degraded
IT WAS REPORTED THAT THE DEVICE HAD A DAMAGED AIR SENSOR SEAL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053958 ↗
MalfunctionJan 13, 2026Crack; Degraded
IT WAS STATED THAT THE DEVICE HAD DAMAGED AIR SENSOR SEAL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053888 ↗
MalfunctionJan 7, 2026Crack
THE CUSTOMER RETURNED THE DEVICE STATING, "THE REMOTE DOSE SOCKET WAS NOT FUNCTIONAL". DURING DEVICE EVALUATION IT WAS FOUND THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23991943 ↗
MalfunctionJan 6, 2026Device Alarm System
IT WAS STATED THAT THE DEVICE HAD A TOO LOW DOWNSTREAM OCCLUSION. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981061 ↗
MalfunctionDec 29, 2025Electrical /Electronic Property Problem; Failure to Infuse; Electrical /Electronic Property Problem; Failure to Infuse
THE CUSTOMER RETURNED THE PRODUCT FOR A RED SCREEN ERROR, DURING DEVICE ANALYSIS, ERROR CODE 41781 WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905655 ↗

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-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-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	`10610586041037`
Brand	CADD
Model	21-2111-0400-51
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.

How reports and recalls are matched · Editorial policy · Report an error on this page