CADD 21-2112-0401-51Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ICU Medical CADD is a patient-controlled infusion pump. The FDA records hold 97 reports, with no deaths and no injuries; many describe the pump failing to infuse or delivering inaccurate amounts, and some describe cracked or torn sensor covers. Reports fell to 14 in the last 12 months from 27 in the prior 12 months. One open recall from February 2024 concerns the pump's labeled uses for intravenous and other infusions.
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
- 1
Summary
The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 15019517101003), received between Sep 25, 2018 and May 20, 2026 — classified as 97 malfunctions.
The most frequently reported specific device problem is “Failure to Infuse” (12 reports).
1 FDA recall record name this device's identifier, 1 still open.
5 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
- 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 Infuse12
- Degraded10
- Crack9
- Inaccurate Delivery8
- Insufficient Flow or Under Infusion8
- Device Alarm System7
- Material Integrity Problem7
- Material Split, Cut or Torn7
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- Insufficient Information17
- No Information6
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Material Split, Cut or Torn
THE DEVICE WAS RETURNED BECAUSE THE BATTERY WAS NOT CHARGING ON THE UNIT. THE RESULTS OF THE INVESTIGATION FOUND THAT THE DEVICE'S DOWNSTREAM OCCLUSION (DSO) SEAL WAS RIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229758 ↗MalfunctionApr 24, 2026Peeled/Delaminated; Improper Flow or Infusion
IT WAS REPORTED THAT THERE WAS A LARGE BUBBLE PRESENT IN THE DOWNSTREAM OCCLUSION SENSOR RUBBER, AND THAT THE POWER BUTTON HAD LOST ITS TACTILE FEEL. THE EVENT OCCURRED DURING INFUSION WITH PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24986380 ↗MalfunctionApr 20, 2026Degraded
IT WAS REPORTED THAT THE DOWNSTREAM OCCLUSION SENSOR COVERS WERE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT AND HARM. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926201 ↗MalfunctionMar 25, 2026Failure to Sense
IT WAS REPORTED THAT THE PUMP EXHIBITED ERROR CODE 41622, OFTEN RELATED TO A MOTOR MALFUNCTION, CAM FLEX SENSOR ISSUE, OR A LOOSE INTERNAL COMPONENT DURING TESTING. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689124 ↗MalfunctionMar 19, 2026Crack
IT WAS REPORTED THAT THE PUMP HAD A DOWNSTREAM OCCLUSION AND COVER WAS TORN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638493 ↗MalfunctionMar 17, 2026Degraded
IT WAS REPORTED THAT THE DEVICE HAD DOWNSTREAM OCCLUSIONS COVER DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617488 ↗MalfunctionMar 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE PUMP WAS FOUND WITH A DOWNSTREAM SENSOR COVER TEAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616608 ↗MalfunctionMar 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE PUMP'S DOWNSTREAM OCCLUSION COVER WAS TORN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616580 ↗MalfunctionMar 13, 2026Failure to Infuse
THE CUSTOMER REPORTED THAT THE PUMP ALARM INDICATED THE CASSETTE WAS NOT CONNECTED CORRECTLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND HARM. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED ISSUE. THIS LED TO INTERRUPTION OF THERAPY WHILE IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589948 ↗MalfunctionMar 3, 2026Material Split, Cut or Torn
THE CUSTOMER RETURNED THE PRODUCT FOR DEVICE HAD A BENT LATCH DURING VISUAL INSPECTION. DEVICE EVALUATION IDENTIFIED A TORN DOWNSTREAM OCCLUSION (DSO) SEAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496158 ↗MalfunctionFeb 11, 2026Degraded
IT WAS REPORTED THAT THE PUMP HAD DOWNSTREAM OCCLUSION ERROR DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE FOUND A BUCKLING UPSTREAM OCCLUSION SEAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316867 ↗MalfunctionJan 6, 2026Degraded
IT WAS REPORTED THAT THE BOLUS PORT WAS FOUND TO BE DAMAGED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE FOUND A DAMAGED DOWNSTREAM OCCLUSION SEAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23977110 ↗MalfunctionNov 11, 2025Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT DEVICE HAD SYSTEM ERROR CODES AND NO ADDITIONAL INFORMATION PROVIDED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ADDITIONALLY, THE INVESTIGATION IDENTIFIED DOWNSTREAM OCCLUSION SEAL DAMAGE, AN ISSUE THAT COULD RESULT IN A HAZARDOUS SITUATION, THEREFORE MAKING THIS INVESTIGATION REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522949 ↗MalfunctionNov 6, 2025Crack; Crack
THE PRODUCT WAS RETURNED FOR INACCURATE VOLUME ACCURACY TEST, DURING INVESTIGATION, A CRACKED DOWNSTREAM OCCLUSION SEAL WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487605 ↗MalfunctionOct 30, 2025Device Sensing Problem; Device Sensing Problem
THE DEVICE EVALUATION IDENTIFIED CRACKED DOWNSTREAM OCCLUSION SEAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424103 ↗MalfunctionSep 8, 2025Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE LATCH/LOCK WAS NOT FUNCTIONING. HOWEVER, EVALUATION OF THE RETURNED DEVICE IDENTIFIED A DEFECTIVE LATCH/LOCK SENSOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994435 ↗MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE WAS RETURNED DUE TO THE POWER PORT NOT RECOGNIZING THE AC ADAPTER. THE RESULTS OF THE INVESTIGATION FOUND THAT THE DEVICE'S DOWNSTREAM OCCLUSION (DSO) SEAL WAS LIFTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22731455 ↗MalfunctionJul 22, 2025Crack; Inaccurate Flow Rate; Crack; Inaccurate Flow Rate
IT WAS REPORTED THAT THE DEVICE FAILED RATE ACCURACY. THERE WAS NO DELAY IN THERAPY. THE EVENT OCCURRED DURING TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566624 ↗MalfunctionJul 18, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THE PUMP FAILED ACCURACY/VERIFICATION TESTING OF VOLUME DELIVERY DUE TO UNKNOWN SOFTWARE ISSUES. THERE WAS NO REPORTED PATIENT INVOLVEMENT. PER REPORTER, THE DEVICE TEST WAS REPEATED A TOTAL OF FOUR TIMES AND WAS FOUND TO BE OUTSIDE OF THE VOLUMETRIC SPECIFICATION. REPORTER STATED THAT THE RETESTING WAS PERFORMED TO CONFIRM THE FIRST EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22546467 ↗MalfunctionJul 14, 2025Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT CONTROLLED ANALGESIC PORT WAS MISSING A PIN AND WAS NOT WORKING. THE DEVICE WAS RETURNED, AND EVALUATION REVEALED A BUCKLED UPSTREAM OCCLUSION SEAL. THE ISSUE WAS DISCOVERED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22499887 ↗MalfunctionJun 9, 2025Crack; Material Twisted/Bent; Crack; Material Twisted/Bent
THE DEVICE WAS RETURNED DUE TO AN ISSUE WITH THE DOWNSTREAM OCCLUSION (DSO) SEAL/PREVENTATIVE MAINTENANCE. THE RESULTS OF THE INVESTIGATION FOUND THAT THE DSO SEAL WAS CRACKING, AND THE UPSTREAM OCCLUSION (USO) SEAL WAS BUCKLING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170493 ↗MalfunctionMay 30, 2025Crack; Crack
IT WAS REPORTED THAT THE DOWNSTREAM OCCLUSION SEAL WAS CRACKED. THE EVENT OCCURRED DURING ROUTINE PREVENTIVE MAINTENANCE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22118210 ↗MalfunctionMay 29, 2025Material Deformation; Material Deformation
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE REMEDIATION INVOLVED A SOFTWARE UPGRADE AT NO CHARGE. THE EVENT HAPPENED DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INVESTIGATION: UPON FURTHER INVESTIGATION FOUND USO (UPSTREAM OCCLUSION) SEAL IS BUCKLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109434 ↗MalfunctionMay 29, 2025Material Deformation; Material Deformation
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE REMEDIATION INVOLVED A SOFTWARE UPGRADE AT NO CHARGE. THE EVENT HAPPENED DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INVESTIGATION: UPON FURTHER INVESTIGATION FOUND USO (UPSTREAM OCCLUSION) SEAL IS BUCKLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22109417 ↗MalfunctionMay 28, 2025Degraded; Device Sensing Problem; Degraded; Device Sensing Problem
IT WAS REPORTED THAT THE DEVICE HAD A CONSTANT CASSETTE ERROR, UNABLE TO CLEAR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22096255 ↗
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-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-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-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 Pump, infusion, pca devices
- Alaris 8120Carefusion 303, Inc. · Pump, infusion, pca2 recalls4 deaths14,640 reports
- CADD 21-2111-0402-51Icu Medical, Inc. · Pump, infusion, pca4 recalls1,535 reports
- CADD 21-2111-0300-01Icu Medical, Inc. · Pump, infusion, pca1 recall1,116 reports
- Alaris™ PCA Module, Model 8120Carefusion 303, Inc. · Pump, infusion, pca2 recalls1 death917 reports
- Nimbus II PlusInfutronix LLC · Pump, Infusion, Pca1 recall1 death800 reports
- CADD 21-2112-0300-01Icu Medical, Inc. · Pump, infusion, pca1 recall406 reports
- CADD 21-6300-51Icu Medical, Inc. · Pump, infusion, pca414 reports
- Nimbus II PainPROInfutronix LLC · Pump, Infusion, Pca2 recalls186 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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