CADD 21-2112-0402-51Recalls & reported problems
Icu Medical, Inc. · Class 2
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 administration set is tubing used to deliver medicine into the spinal canal through a pump. Many of its 453 reports describe pumps failing to deliver fluid, cracked parts and sensing problems, and some describe missed alarms when air was in the line. The reports list no injuries, no deaths and 453 malfunctions. There are 3 recalls, all open, concerning CADD infusion pumps: intermittent alarms that can interrupt an infusion, possible heat damage, and labeled uses.
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
- 469
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 469 adverse event reports that list this exact device (DI 15019517154993), received between Dec 24, 2020 and Sep 25, 2026 — classified as 469 malfunctions.
The most frequently reported specific device problem is “Failure to Infuse” (121 reports).
3 FDA recall records name this device's identifier, 3 still open.
3 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
Recalls naming this device
- Apr 10, 2025Class IOpen, Classified
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Z-1662-2025 · Root cause: Software design · Recall details · FDA record ↗
- Apr 10, 2025Class IOpen, Classified
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Z-1681-2025 · 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-2420-2024 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Infuse121
- Device Alarm System72
- Device Sensing Problem52
- Crack48
- Failure to Sense37
- Degraded27
- Wireless Communication Problem17
- Inaccurate Delivery16
Patient problems
- No Clinical Signs, Symptoms or Conditions434
- Insufficient Information40
- Discomfort2
- No Information2
- Pain1
Recent adverse event reports
The 25 most recent of 469 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Battery Problem
It was found during the investigation of a returned pump that the customer complaint regarding the battery being depleted and the pump not charging when plugged in was confirmed through investigation testing. This issue could potentially interrupt therapy, resulting in a delay in therapy while a replacement pump was obtained. There was no patient involvement and no harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901027 ↗MalfunctionSep 25, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892587 ↗MalfunctionSep 24, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889587 ↗MalfunctionSep 23, 2026Failure to Infuse
It was reported that pump triggered blockage alarm. This high-priority error occurred during patient use; There was a patient involvement, but no patient harm or adverse event reported. However, if this error reoccurs during infusion, it may interrupt therapy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867176 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861282 ↗MalfunctionSep 22, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859359 ↗MalfunctionSep 22, 2026Failure to Sense
It was found during the investigation of a returned pump that an Error "41622" was pops up as soon as the pump turns on due to faulty flex sensor. 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 50855301 ↗MalfunctionSep 21, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845893 ↗MalfunctionSep 17, 2026Failure to Infuse
It was reported that the CADD-Solis pump generated an upstream occlusion alarm despite no occlusion being present. The event occurred during infusion. There was patient involvement; however, no patient harm or adverse event was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803900 ↗MalfunctionSep 15, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780247 ↗MalfunctionSep 9, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699977 ↗MalfunctionSep 9, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680860 ↗MalfunctionSep 8, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678268 ↗MalfunctionSep 8, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677232 ↗MalfunctionSep 3, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50597794 ↗MalfunctionSep 3, 2026Failure to Infuse; Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594694 ↗MalfunctionAug 12, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228025 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223161 ↗MalfunctionAug 11, 2026Improper Flow or Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209959 ↗MalfunctionAug 11, 2026Improper Flow or Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208807 ↗MalfunctionAug 10, 2026Air/Gas in Device
It was reported that the pump did not generate an alarm when air was present in the bag-end section of the tubing. Biomedical personnel evaluated and tested the unit but were unable to replicate the reported issue. The event occurred during use and resulted in a delay in therapy. There was patient involvement; however, no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50193765 ↗MalfunctionAug 10, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192945 ↗MalfunctionAug 7, 2026Failure to Infuse
It was reported that pump triggered frequent alarm and operational stoppages occurred during device operation. There was a patient involvement and there were no additional adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181914 ↗MalfunctionAug 6, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50162826 ↗MalfunctionJul 9, 2026Failure to Infuse; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25763276 ↗
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-1667-2025 · Apr 10, 2025 · Open, ClassifiedCADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SO
- 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-0963-2023 · Dec 9, 2022 · Open, ClassifiedCADD 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)
Other Neuraxial Administration Set - Intrathecal delivery devices
- CADD 21-2112-0402-51LIcu Medical, Inc. · Neuraxial Administration Set - Intrathecal delivery3 recalls129 reports
- CADD 21-2111-0402-78Icu Medical, Inc. · Neuraxial Administration Set - Intrathecal delivery3 recalls5 reports
- CADD 21-2131-25Icu Medical, Inc. · Neuraxial Administration Set - Intrathecal delivery33 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.
How reports and recalls are matched · Editorial policy · Report an error on this page