CADD 2120 (REF 21-2120-0104-01)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 4,043 adverse event reports, including 6 deaths, 4 injuries and 4,033 malfunctions. The reports mostly describe alarm problems, failure to infuse and sensing problems, and some describe pumps finishing infusions early. 2 open recalls: one for possible thermal damage in CADD-Solis pumps, and one tied to software. Reports fell from 863 in the prior 12 months to 285 in the latest 12 months.
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
- 4,097
- Deaths reported
- 6
- Injuries reported
- 4
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 4,097 adverse event reports that list this exact device (DI 15019517126587), received between Jul 11, 2018 and Sep 30, 2026 — classified as 6 deaths, 4 injuries, 4,087 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (1,067 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 System1,067
- Failure to Infuse452
- Device Sensing Problem372
- Degraded232
- Peeled/Delaminated208
- Failure to Sense207
- Insufficient Flow or Under Infusion198
- Audible Prompt/Feedback Problem176
Patient problems
- No Clinical Signs, Symptoms or Conditions3,137
- No Patient Involvement515
- Insufficient Information381
- No Information368
- No Consequences Or Impact To Patient138
- No Known Impact Or Consequence To Patient62
- Air Embolism1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 4,097 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953791 ↗MalfunctionSep 30, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951303 ↗MalfunctionSep 29, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940143 ↗MalfunctionSep 29, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939965 ↗MalfunctionSep 29, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939937 ↗MalfunctionSep 29, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939346 ↗MalfunctionSep 29, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937297 ↗MalfunctionSep 25, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902932 ↗MalfunctionSep 25, 2026Inaccurate Flow Rate
It was reported that during testing, the failed the Downstream Occlusion (DSO) pressure test, with a measured pressure value of 8.47 psi. 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 50897072 ↗MalfunctionSep 24, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887089 ↗MalfunctionSep 23, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875194 ↗MalfunctionSep 23, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874530 ↗MalfunctionSep 23, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874140 ↗MalfunctionSep 23, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873813 ↗MalfunctionSep 23, 2026Failure to Infuse
It was reported that during power-up and bench testing, the CADD-Solis Pump displayed error code 46011 (MP_NEEDS_UPDATE_UNEXPECTEDLY). There was no patient involvement and no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869660 ↗MalfunctionSep 22, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858998 ↗MalfunctionSep 22, 2026Failure to Sense
It was found during the investigation of a returned pump that an "error 41622" was identified in the Event History Log (EHL) This refers to a motor timeout error. This failure condition could potentially interrupt therapy and may stop the pump if it occurs during patient use. There was no patient involvement or harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855417 ↗MalfunctionSep 21, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846707 ↗MalfunctionSep 18, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830694 ↗MalfunctionSep 18, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830418 ↗MalfunctionSep 18, 2026Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828364 ↗MalfunctionSep 18, 2026Failure to Sense
It was reported that the CADD-Solis VIP Ambulatory Infusion Pump had defective cassette sensor. There was no patient involvement and no patient harm. If this malfunction were to occur during patient use, it could interrupt therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825592 ↗MalfunctionSep 18, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822964 ↗MalfunctionSep 18, 2026Device Sensing Problem
It was reported that the CADD-Solis VIP Ambulatory Infusion Pump had a defective cassette sensor during testing. If the malfunction were to recur during patient use, it could prevent proper cassette detection and potentially interrupt or delay infusion therapy. There was no patient involvement or reported patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822650 ↗MalfunctionSep 17, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808674 ↗
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.