CADD 21-2120-0103-51Recalls & reported problems

All models of CADD (123)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 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 is used to deliver medication. Many of its 1,101 reports describe alarm problems, peeling or degraded parts, and failure to infuse. The reports include 1 death and no injuries. Reports fell to 93 in the last 12 months from 244 in the previous 12 months. Two recalls are open, one about possible thermal damage and one with 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: 1,107
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 1,107 adverse event reports that list this exact device (DI 15019517096378), received between Oct 23, 2017 and Sep 29, 2026 — classified as 1 death, 1,106 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (286 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 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 ↗
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

Device Alarm System286
Peeled/Delaminated84
Degraded83
Failure to Infuse74
Device Sensing Problem72
Detachment of Device or Device Component47
Infusion or Flow Problem41
Insufficient Flow or Under Infusion41

Patient problems

No Clinical Signs, Symptoms or Conditions662
No Patient Involvement196
No Information180
Insufficient Information82
No Consequences Or Impact To Patient61
No Known Impact Or Consequence To Patient60
Low Blood Pressure/ Hypotension2
Endocarditis1

Recent adverse event reports

The 25 most recent of 1,107 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 50939854 ↗
MalfunctionSep 25, 2026Device Sensing Problem
It was found during the investigation of a returned pump that the customer complaint regarding the device displaying the error message, "Cassette not attached properly. Reattach cassette," despite the cassette being properly attached, was confirmed through investigation testing. This error code triggers a high-priority alarm, and this issue could potentially interrupt therapy. There was no patient involvement and no harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899846 ↗
MalfunctionSep 23, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873804 ↗
MalfunctionSep 22, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859471 ↗
MalfunctionSep 18, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828467 ↗
MalfunctionSep 10, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723782 ↗
MalfunctionSep 10, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722878 ↗
MalfunctionSep 1, 2026Detachment of Device or Device Component
It was reported that the pump had a detached downstream occlusion seal. The issue was identified during testing. There was no patient involvement and no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550649 ↗
MalfunctionAug 27, 2026Failure to Infuse
It was reported that during infusion, CADD-Solis VIP pump alarmed error code. The infusion was stopped earlier than scheduled. Infusion started on (b)(6)2026 at 14:14 and stopped on (b)(6)-2026 at 09:00. The programmed rate was 2.5 ml per hour, and remaining volume was 0 ml. The total programmed volume was 115 ml. There was patient involvement and no harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484051 ↗
MalfunctionAug 25, 2026Failure to Infuse
The unit underwent preventive maintenance testing, during which a delivery variation of 6% was identified. There was no patient involvement or harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433944 ↗
MalfunctionAug 17, 2026Failure to Infuse
It was reported that the pump displayed error code 44000 during unknown status. There were no patient involvement and harm. However, if this failure reoccurs during infusion, it will interrupt therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287712 ↗
MalfunctionAug 17, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287478 ↗
MalfunctionAug 17, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287213 ↗
MalfunctionAug 17, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287024 ↗
MalfunctionAug 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238038 ↗
MalfunctionAug 11, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209823 ↗
MalfunctionAug 6, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161621 ↗
MalfunctionAug 6, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50157765 ↗
MalfunctionJul 31, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105600 ↗
MalfunctionJul 31, 2026Material Integrity Problem
It was reported that during testing, the downstream occlusion seal of the CADD Solis VIP infusion pump failed to maintain its intended integrity. This issue may lead to inaccurate detection of a downstream occlusion. There was no patient involvement, and no harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105203 ↗
MalfunctionJul 27, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024218 ↗
MalfunctionJul 9, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25770697 ↗
MalfunctionJul 2, 2026Failure to Infuse; Air/Gas in Device
IT WAS REPORTED THAT A CADD PUMP DISPLAYED AN AIR IN LINE ERROR MESSAGE. THIS ERROR TRIGGERS A HIGH-PRIORITY ALARM AND COULD POTENTIALLY INTERRUPT THERAPY. THE EVENT OCCURRED BEFORE THE INFUSION BEGAN IN A CLINICAL SETTING. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25697096 ↗
MalfunctionJun 30, 2026Material Integrity Problem
THE CUSTOMER INITIALLY STATED THAT AN AMBULATORY INFUSION PUMP HAD A LATCH AND LOCK WHICH FAILED TO WORK AND AFTER INVESTIGATION IT WAS FOUND THAT THE PUMP HAD A DAMAGED AIR DETECTOR WHICH CAN LEAD TO INTERRUPTION OF THERAPY. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670782 ↗
MalfunctionJun 30, 2026Detachment of Device or Device Component; Device Sensing Problem
IT WAS REPORTED THAT THE CADD-SOLIS VIP AMBULATORY INFUSION PUMP HAD A RIPPED AND BUBBLED DOWNSTREAM OCCLUSION (DSO) SEAL, AND THE AIR SENSOR WAS FOUND TO BE DETACHED AND FALLING OFF. THE ISSUE WAS IDENTIFIED DURING TESTING. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM. 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 25664788 ↗

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-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	`15019517096378`
Brand	CADD
Model	21-2120-0103-51
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.

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