CADD 21-2120-0105-00Recalls & reported problems
Icu Medical, Inc. · Class 2
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 95 reports, all describing malfunctions, with no deaths and no injuries. The reports mostly describe the pump failing to deliver fluid, sensing and alarm problems, and air in the line, and several recent ones mention events during testing. Two recalls are open: one over possible overheating damage in some CADD-Solis pumps, and the other linked to a software problem.
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
- 97
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 15019517149999), received between Aug 9, 2022 and Sep 21, 2026 — classified as 97 malfunctions.
The most frequently reported specific device problem is “Failure to Infuse” (26 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
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
- Failure to Infuse26
- Device Sensing Problem15
- Failure to Sense13
- Device Alarm System11
- Degraded9
- Obstruction of Flow7
- Air/Gas in Device6
- Detachment of Device or Device Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions95
- Abdominal Pain1
- Fatigue1
- Sleep Dysfunction1
Recent adverse event reports
The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Insufficient Flow or Under Infusion; Failure to Infuse
It was reported that the pump alarmed with a ¿cassette not attached¿ error during infusion, resulting in an extended treatment time and under-delivery. The programmed rate was 2.2 mL/hr, with 92 mL remaining. There was a patient involvement and there were no additional adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842605 ↗MalfunctionSep 10, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722851 ↗MalfunctionAug 17, 2026Excess Flow or Over-Infusion
It was reported that the device may have over-delivered Adrucil. The patient expected a 2-day infusion; however, the device was labeled and programmed for a 24-hour infusion at 4.6 mL/hr. The pump was found empty after approximately 1 day, with 0 mL remaining. The patient was advised to contact the physician immediately due to the discrepancy in infusion duration. There was a patient involvement and there were no additional adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50288070 ↗MalfunctionJul 27, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024795 ↗MalfunctionJul 27, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022909 ↗MalfunctionJul 13, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25804236 ↗MalfunctionMay 11, 2026Air/Gas in Device
IT WAS REPORTED THAT AIR WAS PRESENT IN THE LINE. THE MEDICATION WAS INFUSED AT A PROGRAMMED RATE OF 5.4 ML PER HOUR, WITH A TOTAL PROGRAMMED VOLUME OF 250 ML. THE REMAINING RESERVOIR VOLUME WAS 1.2 ML, AND THE VOLUME DELIVERED WAS 248.85 ML. THE AIR DETECTOR WAS ENABLED (LOW SENSITIVITY), AND THE UPSTREAM SENSOR WAS ALSO ENABLED. IT WAS NOTED THAT THE PUMP SCREEN STILL INDICATED 1.2 ML REMAINING. UPON OBSERVING THE AIR IN THE LINE, THE PUMP WAS IMMEDIATELY STOPPED. THE EVENT OCCURRED WHILE THE DEVICE WAS IN USE WITH A PATIENT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136895 ↗MalfunctionMar 23, 2026Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE PUMP EXHIBITED AN OVER INFUSION DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24666391 ↗MalfunctionFeb 23, 2026Device Alarm System; Air/Gas in Device
IT WAS REPORTED THAT DURING TESTING THE PUMP EXPERIENCED AIR IN LINE ERROR. THERE WERE NO PATIENT INVOLVEMENT AND PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423138 ↗MalfunctionFeb 17, 2026Failure to Sense
IT WAS REPORTED THAT PUMP CASSETTE WAS LOCKED AND THERE WAS A LATCHED ERROR. THE EVENT HAD OCCURRED DURING TESTING. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED ISSUE AND IDENTIFIED A FAULTY LATCH/LOCK FLEX SENSOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369468 ↗MalfunctionFeb 17, 2026Failure to Deliver
IT WAS REPORTED THAT ALARM 46876 OCCURRED. UPON POWERING THE DEVICE BACK ON, A ¿REMOVE AND REATTACH CASSETTE¿ ALARM WAS DISPLAYED, FOLLOWED BY A ¿PATIENT DATA LOST¿ ALARM. TROUBLESHOOTING WAS ATTEMPTED, HOWEVER; THE PATIENT DATA REMAINED LOST. THE EVENT OCCURRED AT THE PATIENT¿S HOME, AND THE DEVICE WAS HANDLED BY A HEALTHCARE PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368557 ↗MalfunctionFeb 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PUMP EXHIBITED A CASSETTE NOT ATTACHED ERROR DURING TESTING. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS A DETACHED DOWNSTREAM OCCLUSION SENSOR. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327165 ↗MalfunctionJan 28, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE DEVICE'S DOWNSTREAM OCCLUSION SEAL WAS RIPPED AND BUBBLED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203320 ↗MalfunctionJan 23, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE DOWNSTREAM OCCLUSION SEAL RIPPED AND IS BUBBLED. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24171750 ↗MalfunctionJan 23, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED THAT THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS RIPPED AND BUBBLED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24171635 ↗MalfunctionJan 23, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE DOWNSTREAM OCCLUSION SEAL IS RIPPED AND BUBBLED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24171473 ↗MalfunctionJan 21, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP HAD DISPLAYED AN ERROR MESSAGE DOWNSTREAM OCCLUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136424 ↗MalfunctionJan 21, 2026Failure to Infuse
IT WAS REPORTED THAT THE PUMP HAD ALARMED FOR "CHECK FOR EMPTY TUBING OR RESERVOIR" ERROR MESSAGE. PER REPORTER, THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136066 ↗MalfunctionJan 6, 2026Failure to Sense
IT WAS REPORTED THAT THE PUMP EXHIBITED A DOWNSTREAM OCCLUSION FAILURE. 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 23981114 ↗MalfunctionDec 4, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE PUMP STATED DOWNSTREAM OCCLUSION, BUT THERE WAS NO OCCLUSION. NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717482 ↗MalfunctionNov 19, 2025Device Sensing Problem; Device Sensing Problem
THE DEVICE WAS RETURNED DUE TO A CASSETTE SENSOR ERROR. THE RESULTS OF THE INVESTIGATION FOUND THAT THE DEVICE'S DOWNSTREAM OCCLUSION (DSO) SENSOR WAS MALFUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23593583 ↗MalfunctionNov 17, 2025Degraded; Failure to Sense; Degraded; Failure to Sense
THE DEVICE WAS RETURNED DUE TO THE FACT THAT IT WAS REPORTED THAT THE DEVICE HAD A DOWNSTREAM OCCLUSION FAILED CALIBRATION. THE RESULTS OF THE INVESTIGATION FOUND THAT THE DEVICE'S DOWNSTREAM OCCLUSION (DSO) SENSOR FAILED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23573338 ↗MalfunctionNov 17, 2025Failure to Sense; Failure to Sense
THE DEVICE WAS RETURNED DUE TO THE CASSETTE SENSOR REPORTEDLY BEING DEFECTIVE. THE RESULTS OF THE INVESTIGATION FOUND AND CONFIRMED THAT THE DEVICE HAD A BAD DOWNSTREAM OCCLUSION (DSO) SENSOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572909 ↗MalfunctionNov 17, 2025Crack; Crack
THE DEVICE WAS RETURNED DUE TO THE DEVICE'S DOWNSTREAM OCCLUSION (DSO) WAS NOT CALIBRATING. THE RESULTS OF THE INVESTIGATION FOUND THAT THE DSO SEAL WAS CRACKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572350 ↗MalfunctionNov 17, 2025Loss of Power; Battery Problem; Loss of Power; Battery Problem
THE DEVICE WAS RETURNED DUE TO A REPORT THAT THE PUMP HAD READ AS LOW BATTERY AND HAD THEN SHUT OFF. THE INVESTIGATION IDENTIFIED THAT THERE WAS A LOSS OF POWER DUE TO DEPLETED BATTERY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572301 ↗
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. 21-2120-0105-12L g. 2
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 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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