CADD 21-2120-0105-01Recalls & 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 ICU Medical CADD infusion pump delivers fluid into the body over time. The reports often describe the pump failing to infuse, false alarms and sensing failures. FDA records list 5,795 reports, 3 deaths, 5 injuries and 5,787 malfunctions. There are 4 open recalls, covering false occlusion alarms that can interrupt an infusion, possible thermal damage in some pumps, and a labeling problem. Reports fell from 1,984 in the prior 12 months to 1,180 in the latest 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: 5,914
Deaths reported: 3
Injuries reported: 5
Recalls naming it: 4

Summary

The FDA's MAUDE database contains 5,914 adverse event reports that list this exact device (DI 15019517150001), received between May 26, 2020 and Sep 30, 2026 — classified as 3 deaths, 5 injuries, 5,906 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (1,141 reports).

4 FDA recall records name this device's identifier, 4 still open.

3 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
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 ↗
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 ↗
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

Failure to Infuse1,141
Device Alarm System888
Device Sensing Problem868
Failure to Sense579
Degraded414
Peeled/Delaminated385
Insufficient Flow or Under Infusion251
Detachment of Device or Device Component221

Patient problems

No Clinical Signs, Symptoms or Conditions5,640
Insufficient Information386
No Information49
No Patient Involvement41
No Consequences Or Impact To Patient12
Balance Problems2
Chest Pain2
Convulsion/Seizure2

Recent adverse event reports

The 25 most recent of 5,914 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954003 ↗
MalfunctionSep 30, 2026Pumping Problem
It was found during the investigation of a returned pump that the customer-reported issue involving a "Cassette Not Properly Attached" alarm was confirmed through investigation testing. This alarm condition is associated with a high-priority alarm and could potentially interrupt therapy if it occurs during patient use. There was no patient involvement or harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949019 ↗
MalfunctionSep 30, 2026Device Sensing Problem
It was reported that during testing the CADD-Solis pump had a defective cassette sensor. There was no patient involvement associated with this event, and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947741 ↗
MalfunctionSep 30, 2026Crack
It was reported that the pump did not maintain the correct date and time. The issue was identified during testing. During inspection of the returned CADD-Solis pump, a cracked downstream occlusion (DSO) seal was observed. There was no patient involvement associated with this event, and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947545 ↗
MalfunctionSep 29, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939982 ↗
MalfunctionSep 29, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939793 ↗
MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939285 ↗
MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939053 ↗
MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938884 ↗
MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938068 ↗
MalfunctionSep 29, 2026Device Sensing Problem
It was reported that the pump had a defective cassette sensor. The event occurred during testing. There was no patient involvement or patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938006 ↗
MalfunctionSep 29, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937964 ↗
MalfunctionSep 29, 2026Pumping Problem
It was reported that the cassette sensor was found to be defective during testing. There was no patient involvement associated with this event, and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936322 ↗
MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933367 ↗
MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932342 ↗
MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925136 ↗
MalfunctionSep 28, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917397 ↗
MalfunctionSep 25, 2026Detachment of Device or Device Component; Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904817 ↗
MalfunctionSep 25, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903511 ↗
MalfunctionSep 25, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903210 ↗
MalfunctionSep 25, 2026Device Sensing Problem
It was identified during the inspection of the returned pump that the event log contained the error message, ¿Cassette Not Attached Properly.¿ This high-priority error was observed during testing. Although no issues were reported during patient use, recurrence of this error during an infusion could interrupt therapy. There was no patient involvement associated with this event, and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903163 ↗
MalfunctionSep 25, 2026Device Sensing Problem
It was reported that, during testing, the CADD-Solis pump was found to have a defective air detector. There was no patient involvement associated with this event, and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903099 ↗
MalfunctionSep 25, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902788 ↗
MalfunctionSep 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902741 ↗
MalfunctionSep 25, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902033 ↗

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-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	`15019517150001`
Brand	CADD
Model	21-2120-0105-01
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.

Other Pump, infusion devices

Alaris 8100
Carefusion 303, Inc. · Pump, infusion
2 recalls2 deaths650,218 reports
Alaris 8100
Carefusion 303, Inc. · Pump, infusion
4 recalls78 deaths344,514 reports
Alaris 8015
Carefusion 303, Inc. · Pump, infusion
2 recalls45 deaths148,093 reports
BD® Alaris™ Pump Module, Model 8100
Carefusion 303, Inc. · Pump, infusion
5 recalls30 deaths51,256 reports
Alaris 8110
Carefusion 303, Inc. · Pump, infusion
2 recalls4 deaths21,956 reports
Alaris 8110
Carefusion 303, Inc. · Pump, infusion
2 recalls2 deaths15,547 reports
Alaris 8015
Carefusion 303, Inc. · Pump, infusion
3 recalls6 deaths13,022 reports
CADD 21-6500-51
Icu Medical, Inc. · Pump, infusion
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