CADD 21-2112-0402-51LRecalls & 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 neuraxial administration set has 122 adverse event reports, with no deaths or injuries. Many reports describe cracks in the membrane found during inspection, along with sensing and infusion failures. Three open recalls name this device: two about false upstream occlusion alarms that can interrupt an active infusion, and one tied to software. Reports rose from 38 in the previous year to 64 in the latest year.
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
- 129
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 15019517155006), received between Nov 2, 2023 and Sep 30, 2026 — classified as 129 malfunctions.
The most frequently reported specific device problem is “Crack” (53 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
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
- Crack53
- Device Sensing Problem15
- Failure to Infuse12
- Failure to Sense11
- Device Alarm System7
- Detachment of Device or Device Component6
- Degraded5
- Air/Gas in Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions123
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 129 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 50953123 ↗MalfunctionSep 25, 2026Defective Alarm; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892620 ↗MalfunctionSep 25, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892619 ↗MalfunctionSep 25, 2026Defective Alarm; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892617 ↗MalfunctionSep 22, 2026Crack
It was reported that the downstream occlusion was damaged(cracked). It occurred during preventive maintenance. There was no patient involvement and harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855524 ↗MalfunctionSep 21, 2026Pumping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845540 ↗MalfunctionSep 9, 2026Failure to Infuse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680850 ↗MalfunctionSep 7, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658653 ↗MalfunctionAug 13, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240281 ↗MalfunctionAug 11, 2026Crack; Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201868 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25816092 ↗MalfunctionJul 14, 2026Crack
IT WAS REPORTED THAT CRACKS FOUND IN THE MEMBRANE OF THE CADD PUMP DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. HOWEVER, IF THIS FAILURE MODE REOCCURS DURING INFUSION IT MAY LEAD TO FLUID INGRESS INTO THE PUMP WHICH WILL INTERRUPT THERAPY AND POTENTIALLY IMPACT PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815848 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815791 ↗MalfunctionJul 14, 2026Crack
IT WAS STATED THAT THERE WAS CRACKS IN THE MEMBRANE. THE ISSUE WAS FOUND DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815633 ↗MalfunctionJul 14, 2026Crack
IT WAS REPORTED THAT CRACKS IN THE MEMBRANE OF THE INFUSION PUMP WERE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815615 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815255 ↗MalfunctionJul 14, 2026Crack
IT WAS REPORTED THAT CRACKS IN THE MEMBRANE OF THE INFUSION PUMP WERE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815190 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815135 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814991 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814937 ↗MalfunctionJul 14, 2026Crack
IT WAS REPORTED THAT CRACKS FOUND IN THE MEMBRANE OF THE CADD PUMP DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. HOWEVER, IF THIS FAILURE MODE REOCCURS DURING INFUSION IT MAY LEAD TO FLUID INGRESS INTO THE PUMP WHICH WILL INTERRUPT THERAPY AND POTENTIALLY IMPACT PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814826 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814809 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25814482 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813657 ↗MalfunctionJul 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813520 ↗
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, ClassifiedCADD 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, ClassifiedCADD-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, 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 21-2112-0402-51Icu Medical, Inc. · Neuraxial Administration Set - Intrathecal delivery3 recalls469 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.
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