CADD 21-2125-0105-01Recalls & reported problems

All models of CADD (123)

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

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019517150148), received between Nov 22, 2021 and Nov 28, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (6 reports).

6 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.

Most reported problems

Device problems

Failure to Sense6
Mechanical Problem6
Mechanical Jam1

Patient problems

No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 28, 2021Mechanical Problem; Failure to Sense; Mechanical Problem; Failure to Sense
INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING OF THIS SMITHS MEDICAL CADD SOLIS PUMP, THE PUMP HAD BLISTER ON THE DOWNSTREAM SENSOR. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12880038 ↗
MalfunctionNov 23, 2021Mechanical Problem; Failure to Sense; Mechanical Problem; Failure to Sense
INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING OF THIS SMITHS MEDICAL CADD SOLIS PUMP, THE PUMP HAD BLISTER ON THE DOWNSTREAM SENSOR. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12863529 ↗
MalfunctionNov 23, 2021Mechanical Problem; Failure to Sense; Mechanical Problem; Failure to Sense
INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING OF THIS SMITHS MEDICAL CADD SOLIS PUMP, THE PUMP HAD BLISTER ON THE DOWNSTREAM SENSOR. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12863347 ↗
MalfunctionNov 23, 2021Mechanical Problem; Failure to Sense; Mechanical Problem; Failure to Sense
INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING OF THIS SMITHS MEDICAL CADD SOLIS PUMP, THE PUMP HAD BLISTER ON THE DOWNSTREAM SENSOR. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12863172 ↗
MalfunctionNov 23, 2021Mechanical Problem; Failure to Sense; Mechanical Jam; Mechanical Problem; Failure to Sense; Mechanical Jam
INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING OF THIS SMITHS MEDICAL CADD SOLIS PUMP, THE PUMP HAD BLISTER ON THE DOWNSTREAM SENSOR. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12858830 ↗
MalfunctionNov 22, 2021Mechanical Problem; Failure to Sense; Mechanical Problem; Failure to Sense
INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING OF THIS SMITHS MEDICAL CADD SOLIS PUMP, THE PUMP HAD BLISTER ON THE DOWNSTREAM SENSOR. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12858157 ↗

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-1682-2025 · Apr 10, 2025 · Open, Classified
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP
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-2421-2024 · Feb 27, 2024 · Open, Classified
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proxi
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	`15019517150148`
Brand	CADD
Model	21-2125-0105-01
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.

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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
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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