CADD 21-2111-0402-51LRecalls & reported problems

All models of CADD (123)

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

3 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 has 122 adverse event reports, with no deaths or injuries. Reports most often describe the pump failing to infuse or sense, parts detaching or cracking, and alarm problems. Three open recalls name this device: two about false upstream occlusion alarms that can interrupt an active infusion, and one tied to 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: 127
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 3

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 15019517154986), received between Apr 12, 2023 and Sep 30, 2026 — classified as 127 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (26 reports).

3 FDA recall records name this device's identifier, 3 still open.

4 other recalls cover devices cleared under the same FDA submission (K170982); 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
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, 2025Class IOpen, 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, 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

Failure to Infuse26
Device Sensing Problem23
Detachment of Device or Device Component17
Device Alarm System12
Crack11
Failure to Sense11
Material Split, Cut or Torn8
Degraded7

Patient problems

No Clinical Signs, Symptoms or Conditions123
Insufficient Information5
Pain1

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951657 ↗
MalfunctionSep 9, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698890 ↗
MalfunctionSep 7, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650842 ↗
MalfunctionSep 3, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594184 ↗
MalfunctionSep 2, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571827 ↗
MalfunctionAug 28, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502939 ↗
MalfunctionAug 17, 2026Failure to Infuse
It was reported that the pump displayed "error code 41786" during acceptance check. There were no patient involvement and harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286598 ↗
MalfunctionAug 17, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279194 ↗
MalfunctionAug 17, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50276340 ↗
MalfunctionAug 13, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241029 ↗
MalfunctionAug 11, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50203341 ↗
MalfunctionAug 5, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50148795 ↗
MalfunctionAug 4, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133843 ↗
MalfunctionAug 4, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133759 ↗
MalfunctionJul 31, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099593 ↗
MalfunctionJul 13, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25803184 ↗
MalfunctionJun 23, 2026Device Sensing Problem
IT WAS STATED THAT THE PUMP DOESN'T IDENTIFY THE CARTRIDGE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS OBSERVED DURING INSPECTION OF A RETURNED PUMP THAT DOWNSTREAM OCCLUSION SENSOR WAS DEFECTIVE. THE FAILURE MODE WAS FOUND BEFORE PATIENT USE. HOWEVER, IF THE ISSUE REOCCURS DURING INFUSION, IT WILL INTERRUPT THERAPY AND POTENTIALLY AFFECT THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25599497 ↗
MalfunctionMay 28, 2026Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PUMP EXHIBITED A TEAR IN THE MEMBRANE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323075 ↗
MalfunctionMay 8, 2026Failure to Infuse; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE DEVICE HAS INTERMITTENT ERROR 45520 WHEN NOT IN USE. THERE WAS NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129883 ↗
MalfunctionMay 6, 2026Device Sensing Problem
IT WAS REPORTED THAT A CADD SOLIS HPCA PUMP EXPERIENCED A CONSTANT ALARM FOR UPSTREAM OCCLUSION WHEN THERE IS NO OCCLUSION. THE MALFUNCTION REPRESENTS A POTENTIAL RISK IF IT WERE TO RECUR DURING THERAPY AND THAT COULD LEAD TO INTERRUPTION OF INFUSION OR THERAPY DELIVERY. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25093666 ↗
MalfunctionApr 6, 2026Failure to Infuse; Obstruction of Flow
THE PUMP DISPLAYED A DOWNSTREAM OCCLUSION ALARM, ALTHOUGH A THOROUGH CHECK OF THE LINE REVEALED NO ACTUAL OCCLUSION. THERE WAS NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792371 ↗
MalfunctionApr 1, 2026Crack; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED PUMP HAD DOWNSTREAM OCCLUSION MEMBRANE DAMAGE. THIS EVENT OCCURRED DURING PREVENTIVE MAINTENANCE. PHOTO SAMPLES WAS PROVIDED, WHICH DEMONSTRATED THE SEAL WAS COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757899 ↗
MalfunctionMar 19, 2026Device Sensing Problem
IT WAS REPORTED THAT THE PUMP HAD ALARMED ¿DOWNSTREAM OCCLUSION¿ PRIOR TO PRIMING. NEW TUBING HAD BEEN TRIED, BUT THE ISSUE HAD BEEN DETERMINED TO BE WITH THE PUMP ITSELF. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639911 ↗
MalfunctionMar 5, 2026Failure to Sense
IT WAS REPORTED THAT THE DEVICE PRESENTS AN ALARM CASSETTE LOCKED BUT NOT LATCHED WHILE IT IS STILL LOCKED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24522997 ↗
MalfunctionMar 3, 2026Device Alarm System
IT WAS REPORTED THAT THE PUMP IS NOT PRIMING AND IS SENSITIVE TO UPSTREAM OCCLUSIONS. ALSO, DURING TESTING THE PUMP WAS FREQUENTLY ALARMING, AND SELF-CLEARING FOR UPSTREAM OCCLUSIONS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24495460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170982. One submission often covers many models, so check the product and lot details in each record.

Z-1662-2025 · Apr 10, 2025 · Open, Classified
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUM
Z-1681-2025 · Apr 10, 2025 · Open, Classified
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW,
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-0963-2023 · Dec 9, 2022 · Open, Classified
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8)

Device details

UDI-DI	`15019517154986`
Brand	CADD
Model	21-2111-0402-51L
Company	Icu Medical, Inc.
Product code	MEA · Pump, infusion, pca
Class	Class 2
FDA submission	K170982
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
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, pca devices

Alaris 8120
Carefusion 303, Inc. · Pump, infusion, pca
2 recalls4 deaths14,640 reports
CADD 21-2111-0402-51
Icu Medical, Inc. · Pump, infusion, pca
4 recalls1,535 reports
CADD 21-2111-0300-01
Icu Medical, Inc. · Pump, infusion, pca
1 recall1,116 reports
Alaris™ PCA Module, Model 8120
Carefusion 303, Inc. · Pump, infusion, pca
2 recalls1 death917 reports
Nimbus II Plus
Infutronix LLC · Pump, Infusion, Pca
1 recall1 death800 reports
CADD 21-2112-0300-01
Icu Medical, Inc. · Pump, infusion, pca
1 recall406 reports
CADD 21-6300-51
Icu Medical, Inc. · Pump, infusion, pca
414 reports
Nimbus II PainPRO
Infutronix LLC · Pump, Infusion, Pca
2 recalls186 reports

All Pump, infusion, pca 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