CADD 2120 (REF 21-2127-0104-01)Recalls & reported problems
Icu Medical, Inc. · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ICU Medical CADD 2120 infusion pump has 1,249 adverse event reports, including 3 deaths and 1 injury. Many reports describe alarms that could interrupt therapy, failure to deliver fluid, and error codes during maintenance or testing. There are 2 open recalls, one about possible heat damage in CADD-Solis pumps. Reports in the last 12 months (127) are fewer than in the 12 months before (321).
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
- 1,256
- Deaths reported
- 3
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,256 adverse event reports that list this exact device (DI 15019517126600), received between Mar 23, 2018 and Sep 24, 2026 — classified as 3 deaths, 1 injury, 1,252 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (345 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
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 · 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 · FDA record ↗
Most reported problems
Device problems
- Device Alarm System345
- Failure to Infuse117
- Degraded105
- Peeled/Delaminated100
- Device Sensing Problem89
- Failure to Sense67
- Excess Flow or Over-Infusion63
- Detachment of Device or Device Component53
Patient problems
- No Clinical Signs, Symptoms or Conditions900
- No Patient Involvement170
- No Information157
- Insufficient Information97
- No Consequences Or Impact To Patient49
- No Known Impact Or Consequence To Patient8
- Cough1
- Decreased Appetite1
Recent adverse event reports
The 25 most recent of 1,256 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889114 ↗MalfunctionSep 18, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828495 ↗MalfunctionSep 15, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777444 ↗MalfunctionSep 9, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699281 ↗MalfunctionSep 9, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698803 ↗MalfunctionSep 8, 2026Mechanical Problem; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675097 ↗MalfunctionSep 8, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674815 ↗MalfunctionAug 27, 2026Failure to Infuse; Detachment of Device or Device Component
The customer returned the device stating, "During preventive maintenance pump has error code 41786". Upon device evaluation the error was noted on event history log, and additionally Downstream occlusion seal was noted to be detached. This issue may lead to fluid ingress. There was no patient involvement and no harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484992 ↗MalfunctionAug 26, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455365 ↗MalfunctionAug 18, 2026Failure to Infuse
During the investigation of a returned pump, it was confirmed that the customer's complaint regarding the device displaying error code "41541" could be reproduced through investigative testing. This error code triggers a high-priority alarm and could potentially interrupt therapy. There was no patient involvement, and no harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306192 ↗MalfunctionAug 13, 2026Defective Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241297 ↗MalfunctionAug 12, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223032 ↗MalfunctionJul 14, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815219 ↗MalfunctionJul 2, 2026Failure to Infuse
IT WAS REPORTED THAT PUMP HAS "CASSETTE NOT ATTACHED PROPERLY" ERROR WHEN NO CASSETTE IS ATTACHED OCCURRED DURING TESTING. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THERE WAS "CASSETTE NOT ATTACHED PROPERLY" ALARM IN THE EVENT HISTORY LOG. THIS INDICATES A HIGH-PRIORITY ALARM WHICH WILL STOP THE INFUSION DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25696710 ↗MalfunctionJun 30, 2026Failure to Infuse
IT WAS REPORTED THAT THE CADD PUMP REPEATEDLY GENERATED A HIGH-PRIORITY AIR IN LINE ALARM, WHICH COULD POTENTIALLY INTERRUPT THERAPY IF IT RECURRED DURING PATIENT USE. ADDITIONALLY, AN ISSUE WITH THE BATTERY CASE HINGE WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT OR REPORTED HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25666056 ↗MalfunctionJun 29, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP WAS BEEPING UPON POWER ON AND DISPLAYED ERROR CODE ¿41622¿ DURING TESTING. DURING INVESTIGATION, IT WAS CONFIRMED THAT ¿41622¿ ERROR CODE DOES APPEAR IN EVENT LOG OF THE RETURNED PUMP. THIS HIGH-PRIORITY ERROR OCCURRED DURING TESTING; HOWEVER, IF THIS ERROR OCCURS DURING INFUSION, IT WILL INTERRUPT THERAPY AND POTENTIALLY IMPACT PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25657126 ↗MalfunctionJun 1, 2026Circuit Failure
IT WAS REPORTED THAT PUMP HAD ERROR CODE 45169. THE EVENT OCCURRED DURING TESTING. DURING INVESTIGATION FOUND THE ERROR CODE 45169 WHICH WAS CONFIRMED IN EVENT LOGS. THIS MALFUNCTION MAKES THE EVENT REPORTABLE. THERE ARE NO PATIENT INVOLVEMENT AND ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354631 ↗MalfunctionMay 29, 2026Failure to Sense
IT WAS REPORTED THAT THE PUMP EXHIBITED A CASSETTE NOT ATTACHED PROPERLY ERROR. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS A DOWNSTREAM OCCLUSION SENSOR ISSUE. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333472 ↗MalfunctionMay 28, 2026Intermittent Loss of Power
IT WAS REPORTED THAT THE DEVICE POWERS ON AND IMMEDIATELY POWERS DOWN. UNABLE TO SUCCESSFULLY POWER ON THE DEVICE. THE EVENT OCCURRED DURING TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323177 ↗MalfunctionMay 27, 2026Detachment of Device or Device Component; Device Sensing Problem
IT WAS REPORTED THAT THE CADD-SOLIS VIP PUMP HAD A MALFUNCTION OF LIFTING DSO SEAL DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25307308 ↗MalfunctionMay 8, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP HAD AIR IN THE LINE. THERE WAS NO PATIENT INVOLVEMENT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128772 ↗MalfunctionMay 8, 2026Crack
IT WAS REPORTED THAT THE DOWNSTREAM OCCLUSION DIAPHRAGM IN THE PUMP WAS CRACKED. THE DEVICE MALFUNCTION WAS FOUND DURING PREVENTIVE MAINTENANCE TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123117 ↗MalfunctionMay 5, 2026Failure to Infuse
IT WAS REPORTED THAT THE DEVICE DISPLAYS A RED ERROR CODE SCREEN WHEN FIRST TURNED ON, ERROR CODE 45985. DEVICE ALSO DOES NOT MAKE ANY NOISE. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085290 ↗MalfunctionMay 1, 2026Device Sensing Problem
IT WAS REPORTED THAT THE PUMP WAS NOT DETECTING THE CASSETTE WHEN IT IS IN PLACE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061147 ↗MalfunctionMay 1, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP ALARMED WITH FOR ¿CHECK FOR EMPTY TUBING OR RESERVOIR¿ MESSAGE AND ¿REMOVE AND REATTACH CASSETTE¿ THE PUMP CONTINUED ALARMING AND ISSUE COULD NOT BE RESOLVED. THE MEDICATION BEING INFUSED WAS ROPIVICAINE WITH PROGRAMMED RATE AT 0¿ML PER HOUR, THE REMAINING VOLUME WAS 431.9 ML, AND VOLUME GIVEN WAS 0 ML. THE EVENT OCCURRED DURING WHILE IN USE WITH THE PATIENT AND THERE WAS NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25060907 ↗
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, ClassifiedCADD-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, ClassifiedCADD-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, Classifiedsmiths 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 · TerminatedCADD-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
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.