CADD 21-2112-0100-51Recalls & 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 Solis VIP is an ambulatory infusion pump, a portable pump that delivers medicine without the patient being tethered to a wall. The 59 reports mostly describe the pump alarming falsely, failing to sense air in the line, missing buttons on the keypad, and stopping or refusing to start an infusion, which can interrupt therapy. No deaths or injuries are reported. Two open recalls name this pump line, one about possible thermal damage and one about the range of uses it is cleared for.

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: 59
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10610586039232), received between May 14, 2018 and Jul 14, 2026 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (10 reports).

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

7 other recalls cover devices cleared under the same FDA submission (K072144); 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-1681-2025 · 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-2420-2024 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗

Most reported problems

Device problems

Device Alarm System10
Infusion or Flow Problem8
Degraded7
Device Sensing Problem6
Failure to Sense5
Air/Gas in Device4
Excess Flow or Over-Infusion4
Failure to Infuse4

Patient problems

No Clinical Signs, Symptoms or Conditions41
Insufficient Information9
No Patient Involvement7
No Information5
No Known Impact Or Consequence To Patient4
No Consequences Or Impact To Patient1

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 14, 2026Mechanical Problem; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25816043 ↗
MalfunctionMay 12, 2026Failure to Infuse
IT WAS REPORTED THAT WHEN CONNECTING THE PUMP TO THE LINE AND ATTEMPTING TO START IT, THE SYSTEM DISPLAYS AN ¿AIR IN LINE¿ ERROR. THERE WAS NO PATIENT INVOLVEMENT AND HARM. THIS COULD CAUSE INTERRUPTION OF THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25154601 ↗
MalfunctionSep 9, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE ACCURACY TEST FAILED. THE EVENT OCCURRED DURING TESTING. THE DEVICE EVALUATION FOUND AN ISSUE WITH THE DOWNSTREAM OCCLUSION SENSOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23006317 ↗
MalfunctionAug 14, 2025Device Sensing Problem; Device Sensing Problem
THE CUSTOMER RETURNED THE PRODUCT FOR THE BUTTON PORT NOT FUNCTIONING, AND DURING PHYSICAL INSPECTION IT WAS FOUND THAT THE UPSTREAM OCCLUSION (USO) SENSOR WAS FAILING. AFTER INVESTIGATION THE RESULTS INDICATED A REPORTABLE MALFUNCTION DUE TO THE FAILING USO SENSOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22804131 ↗
MalfunctionMar 27, 2025Degraded; Degraded
IT WAS REPORTED THAT THE PUMP DID NOT MAINTAIN THE DATE AND TIME. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS A DAMAGED AIR DETECTOR. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21712753 ↗
MalfunctionMar 26, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PUMP WAS NOT WORKING. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS A LIFTED DOWNSTREAM OCCLUSION SEAL AND BUCKLED UPSTREAM OCCLUSION SEAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21701525 ↗
MalfunctionMar 5, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE DEVICE WAS NOT RECOGNIZING BUTTONS WHEN PLUGGED IN, AND THERE WAS NO VISUAL DAMAGE TO THE PORT. THE CUSTOMER RETURNED THE PRODUCT FOR REPAIR, AND DURING PHYSICAL INSPECTION IT WAS FOUND THAT THE KEYPAD ON THE PUMP WAS FAULTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21530008 ↗
MalfunctionJan 23, 2025Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THERE WAS AN AIR IN LINE SENSOR THAT WAS UNRESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21223192 ↗
MalfunctionJan 3, 2025Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE AIR DETECTOR WAS UNRESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE WAS DISCOVERED DURING TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072229 ↗
MalfunctionNov 22, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE DEVICE DISPLAYED CASSETTE NOT ATTACHED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20757579 ↗
MalfunctionNov 1, 2024Failure to Pump; Improper Flow or Infusion; Failure to Pump; Improper Flow or Infusion
IT WAS REPORTED THAT THE DEVICE WAS NOT PUMPING MEDICINE AND THE MEDICINE WAS POSSIBLY FREE-FLOWING. PER REPORTER,T HE ISSUE WAS FOUND DURING PROGRAMMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20589067 ↗
MalfunctionNov 1, 2024Improper Flow or Infusion; Key or Button Unresponsive/not Working; Improper Flow or Infusion; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT A FULL BAG WAS ADMINISTERED WITHOUT ISSUE. THE SECOND BAG APPEARED TO BE WORKING BUT DID NOT ADMINISTER MEDICATION WHEN PATIENT WAS PRESSING BUTTON FOR MORE MEDICATION. THE ISSUE WAS FOUND DURING PATIENT USE. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20589044 ↗
MalfunctionNov 1, 2024Crack; Failure to Sense; Failure to Infuse; Crack; Failure to Sense; Failure to Infuse
IT WAS REPORTED THAT THE DEVICE WAS NOT RECOGNIZING THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20589034 ↗
MalfunctionOct 30, 2024Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE PUMP DIDN'T INFUSE ANY OF THE MEDICATION EVEN THOUGH THE DEVICE SAID THAT IT WAS INFUSING. THE PATIENT WAS NOT HARMED AND NO ADVERSE EFFECTS WERE NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20566373 ↗
MalfunctionOct 15, 2024Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE HAD A CASSETTE SENSOR ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451875 ↗
MalfunctionOct 15, 2024Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE HAD A CASSETTE SENSOR ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451788 ↗
MalfunctionOct 9, 2024Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE AIR IN LINE SENSOR WAS UNRESPONSIVE. THE EVENT OCCURRED DURING TESTING, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20408318 ↗
MalfunctionSep 11, 2024Circuit Failure; Circuit Failure
IT WAS REPORTED THAT THERE WAS AN ERROR CODE 41786. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20192754 ↗
MalfunctionSep 11, 2024Circuit Failure; Circuit Failure
IT WAS REPORTED THAT THERE WAS AN ERROR CODE 42222. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20192377 ↗
MalfunctionAug 27, 2024Degraded; Material Separation; Failure to Infuse; Degraded; Material Separation; Failure to Infuse
IT WAS REPORTED THAT THE DEVICE EXHIBITED ERROR CODE 45986 AND HAD DOWNSTREAM OCCLUSION (DSO) DAMAGED. THE EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20079211 ↗
MalfunctionAug 23, 2024Degraded; Air/Gas in Device; Degraded; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ERROR, AND TEAR ON AIR IN LINE SEAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20053881 ↗
MalfunctionAug 23, 2024Degraded; Air/Gas in Device; Degraded; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ERROR, AND TEAR ON AIR IN LINE SEAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20053461 ↗
MalfunctionAug 23, 2024Degraded; Air/Gas in Device; Degraded; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ERROR, AND TEAR ON AIR IN LINE SEAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20053292 ↗
MalfunctionAug 23, 2024Degraded; Air/Gas in Device; Degraded; Air/Gas in Device
IT WAS REPORTED THAT THE DEVICE HAD AN AIR IN LINE ERROR, AND A TEAR ON THE AIR IN LINE SEAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20052353 ↗
MalfunctionAug 23, 2024Degraded; Failure to Sense; Obstruction of Flow; Degraded; Failure to Sense; Obstruction of Flow
IT WAS REPORTED THAT THE DEVICE HAD A DOWNSTREAM OCCLUSION (DSO) & CASSETTE NOT ATTACHED ERRORS. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20051800 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072144. One submission often covers many models, so check the product and lot details in each record.

Z-1667-2025 · Apr 10, 2025 · Open, Classified
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SO
Z-2419-2024 · Feb 27, 2024 · Open, Classified
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximi
Z-1813-2015 · May 26, 2015 · Terminated
CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospita
Z-0166-2015 · Sep 29, 2014 · Terminated
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a
Z-0004-2012 · May 10, 2011 · Terminated
Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcuta
Z-1033-2011 · Jan 13, 2011 · Terminated
Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-
Z-1082-2010 · Jan 27, 2010 · Terminated
Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD-Solis ambulatory infusion pumps, Model 2100. These cords we

Device details

UDI-DI	`10610586039232`
Brand	CADD
Model	21-2112-0100-51
Company	Icu Medical, Inc.
Product code	MEA · Pump, infusion, pca
Class	Class 2
FDA submission	K072144
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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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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