CADD 21-2120-0102-51Recalls & reported problems

All models of CADD (123)

Data updated Oct 16, 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 VIP infusion pump from ICU Medical is a portable pump for delivering medicine. Many reports describe alarms, pumps failing to deliver medicine, and sensor problems. The 3,514 reports include 2 deaths and 5 injuries. There are 4 recalls, all open, over false alarms that can interrupt an infusion and possible heat damage to the pumps. Reports fell to 335 in the last 12 months from 750 in the previous 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: 3,555
Deaths reported: 2
Injuries reported: 5
Recalls naming it: 4

Summary

The FDA's MAUDE database contains 3,555 adverse event reports that list this exact device (DI 10610586042829), received between Jun 16, 2017 and Sep 30, 2026 — classified as 2 deaths, 5 injuries, 3,547 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (812 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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Apr 10, 2025Open, 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, 2025Open, 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, 2025Open, 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 ↗
Feb 27, 2024Open, 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 System812
Failure to Infuse448
Device Sensing Problem349
Failure to Sense212
Degraded192
Excess Flow or Over-Infusion174
Volume Accuracy Problem138
Peeled/Delaminated123

Patient problems

No Clinical Signs, Symptoms or Conditions2,296
No Patient Involvement461
Insufficient Information427
No Information399
No Consequences Or Impact To Patient214
No Known Impact Or Consequence To Patient183
Patient Problem/Medical Problem4
Death3

Recent adverse event reports

The 25 most recent of 3,555 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Pumping Problem
It was reported that, upon inspection of the returned CADD-Solis Pump, a Cassette Not Attached error was confirmed through functional testing. In addition, a defective downstream occlusion (DSO) sensor was identified during the evaluation. 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 50949309 ↗
MalfunctionSep 29, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936865 ↗
MalfunctionSep 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903082 ↗
MalfunctionSep 25, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903005 ↗
MalfunctionSep 25, 2026Pumping Problem
It was reported that the Medfusion 4000 Syringe Infusion Pump displayed a ¿Primary Audible Alarm BGND Test¿ message and measured 8 ohms during testing. The reported high-priority audible alarm issue could result in an interruption of therapy. Patient involvement and patient harm were not reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897658 ↗
MalfunctionSep 25, 2026Failure to Infuse
It was reported that the CADD-Solis VIP Ambulatory Infusion Pump experienced an occlusion error while in use with a patient resulting in an interruption of therapy. There was patient involvement; however, no patient harm or adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897496 ↗
MalfunctionSep 25, 2026Failure to Infuse
It was reported that the CADD-Solis HPCA Pump repeatedly displayed System Error 41622 (ERROR_MOTOR_TIMEOUT). The error was observed frequently in the device report log will result in an interruption of therapy. There was no reported patient involvement, patient harm, or adverse event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897168 ↗
MalfunctionSep 25, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896870 ↗
MalfunctionSep 24, 2026Material Separation; Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891490 ↗
MalfunctionSep 24, 2026Material Separation; Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891237 ↗
MalfunctionSep 24, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890912 ↗
MalfunctionSep 24, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890850 ↗
MalfunctionSep 24, 2026Material Separation; Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890627 ↗
MalfunctionSep 24, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890451 ↗
MalfunctionSep 24, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890004 ↗
MalfunctionSep 24, 2026Inaccurate Flow Rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889618 ↗
MalfunctionSep 24, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889404 ↗
MalfunctionSep 24, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883826 ↗
OtherSep 23, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875004 ↗
MalfunctionSep 23, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863047 ↗
MalfunctionSep 22, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860278 ↗
MalfunctionSep 22, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859062 ↗
MalfunctionSep 22, 2026Pumping Problem
It was reported that pump experienced error message key stuck and battery damage, a high-priority alarm which if recur during use can interrupt therapy. This event occurred during set up. There was no patient involvement and harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855085 ↗
MalfunctionSep 22, 2026Improper Flow or Infusion
It was reported that the pump was not infusing properly. It occurred while in use with a patient. There was patient involvement but no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853798 ↗
MalfunctionSep 22, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853654 ↗

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. 21-2120-0105-12

Device details

UDI-DI	`10610586042829`
Brand	CADD
Model	21-2120-0102-51
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 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.

Other Pump, infusion devices

Alaris 8100
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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