CADD 21-2127-0105-01Recalls & 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 CADD infusion pump from ICU Medical has 1,445 FDA adverse event reports, with 2 injuries, 1,443 malfunctions and no deaths. They mostly describe alarm problems, peeling parts, sensing problems and the pump failing to infuse. Reports fell to 135 in the last 12 months from 483 in the 12 months before. Two open recalls name this device: one for possible heat damage, and one whose listed root cause is software.

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: 1,466
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 1,466 adverse event reports that list this exact device (DI 15019517150292), received between Oct 2, 2020 and Sep 30, 2026 — classified as 2 injuries, 1,464 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (208 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 System208
Peeled/Delaminated174
Failure to Infuse147
Device Sensing Problem146
Degraded129
Failure to Sense104
Insufficient Flow or Under Infusion101
Volume Accuracy Problem98

Patient problems

No Clinical Signs, Symptoms or Conditions1,239
No Patient Involvement154
Insufficient Information97
No Information33
No Consequences Or Impact To Patient3
Cardiac Arrest1
Hypoglycemia1

Recent adverse event reports

The 25 most recent of 1,466 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949001 ↗
MalfunctionSep 28, 2026Failure to Infuse
It was reported that the cassette sensor indicated that the cassette was not attached properly. The event occurred during routine preventive maintenance. During investigation of the returned CADD pump, the error "Cassette Not Attached Properly" was identified in the event log. This high-priority error was confirmed during preventive maintenance. However, if the issue were to recur during an infusion, it could result in an interruption of 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 50923420 ↗
MalfunctionSep 25, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892629 ↗
MalfunctionSep 25, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892628 ↗
MalfunctionSep 25, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892627 ↗
MalfunctionSep 23, 2026Failure to Infuse
It was reported that, upon inspection of the returned CADD-Solis pump, a Cassette Not Attached error was identified during downstream occlusion (DSO) sensor testing. There was no patient involvement and harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873379 ↗
MalfunctionSep 21, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848342 ↗
MalfunctionSep 21, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846524 ↗
MalfunctionSep 21, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846156 ↗
MalfunctionSep 18, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830656 ↗
MalfunctionSep 18, 2026Inaccurate Delivery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824773 ↗
MalfunctionSep 17, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810609 ↗
MalfunctionSep 16, 2026Failure to Infuse
It was reported that during testing, the CADD-Solis VIP Ambulatory Infusion Pump exhibited a defective cassette sensor condition. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791331 ↗
MalfunctionSep 15, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780051 ↗
MalfunctionSep 15, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779856 ↗
MalfunctionSep 9, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699303 ↗
MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698771 ↗
MalfunctionSep 7, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657770 ↗
MalfunctionSep 2, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566785 ↗
MalfunctionAug 25, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440282 ↗
MalfunctionAug 14, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254972 ↗
MalfunctionAug 13, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241959 ↗
MalfunctionAug 13, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50239372 ↗
MalfunctionAug 13, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237823 ↗
MalfunctionAug 12, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225576 ↗

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	`15019517150292`
Brand	CADD
Model	21-2127-0105-01
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

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2 recalls45 deaths148,093 reports
BD® Alaris™ Pump Module, Model 8100
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Alaris 8110
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Alaris 8110
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Alaris 8015
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3 recalls6 deaths13,022 reports
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.

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