CADD 21-2120-0103-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 585 adverse event reports that list this exact device (DI 15019517084368), received between Mar 15, 2018 and Sep 25, 2026 — classified as 585 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (197 reports).

4 FDA recall records name this device's identifier, 4 still open.

3 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.

Recalls naming this device

1. 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 ↗

2. 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 ↗

3. 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 ↗

4. 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

Recent adverse event reports

The 25 most recent of 585 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device Alarm System; High Test Results

  It was reported that the pump failed the volume test, with a measured value of 22.80. The event occurred during testing. 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 50897207 ↗
• MalfunctionJul 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CADD PUMP HAD BOTH THE AIR SENSOR AND DOWNSTREAM OCCLUSION SEAL UNATTACHED AND FALLING OFF. THIS EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825488 ↗
• MalfunctionMay 8, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP EXPERIENCED A LATCHING ALARM. THE EVENT OCCURRED DURING TESTING. FOUND THE DOWNSTREAM OCCLUSION SENSOR WAS DEFECTIVE. INVESTIGATION FOUND THE DOWNSTREAM OCCLUSION SENSOR WAS DEFECTIVE. THIS COULD CAUSE INTERRUPTION OF THERAPY. THE FILE IS REPORTABLE BASED OFF THE INVESTIGATION FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123196 ↗
• MalfunctionMay 4, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO HAVE A DOWNSTREAM OCCLUSION DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069708 ↗
• MalfunctionApr 13, 2026Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PUMP HAD DSO SENSOR BUBBLED AND UNATTACHED AND DEVICE ALSO STATED, "PUMP SETTING AND PATIENT DATA LOST" INDICATING INTERIOR BATTERY IS HAS A PROBLEM WITH IT, THE EVENT OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858928 ↗
• MalfunctionApr 8, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PUMP WAS ALARMING EMPTY EARLIER THAN EXPECTED. THE PUMP WAS REVIEWED AND SHOWED A TOTAL GIVEN OF 98.7 ML SINCE 17-FEB-2026. THE MEDICATION LABEL CONFIRMED 5FU(5-FLUOROURACIL), TOTAL VOLUME 100 ML, SET FOR CONTINUOUS INFUSION OVER 120 HOURS (5 DAYS). THE EVENT OCCURRED DURING INFUSION, WITH PATIENT INVOLVEMENT AND NO HARM. IT TOOK PLACE AT THE PATIENT¿S HOME, AND THE DEVICE WAS OPERATED BY A HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823379 ↗
• MalfunctionApr 3, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP GAVE ERROR CODE 42221, 040100. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776512 ↗
• MalfunctionApr 2, 2026Collapse; Contamination

  IT WAS REPORTED THAT THE SCREEN TURNS WHITE AND PUMP GIVES AN ALARM, WHEN BATTERIES ARE IN AND IT WAS FOUND OUT DURING TESTING. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24768312 ↗
• MalfunctionMar 18, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP HAD A CASSETTE NOT ATTACHED ERROR AND IT WAS FOUND OUT DURING TESTING. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE ERROR WAS DUE TO A FAULTY DOWNSTREAM OCCLUSION SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627668 ↗
• MalfunctionMar 17, 2026Failure to Sense

  THE DEVICE WAS RETURNED DUE TO CASSETTE NOT ATTACHED ERROR. UPON PHYSICAL INSPECTION, DOWNSTREAM OCCLUSION (DSO) SENSOR, AND THE DSO SEAL WERE ALSO FOUND TO BE DETACHED. THESE WERE DETERMINED TO BE A REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621363 ↗
• MalfunctionMar 12, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP DID NOT INFUSE. THE EVENT OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580731 ↗
• MalfunctionMar 6, 2026Material Split, Cut or Torn

  IT WAS FOUND DURING INVESTIGATION THAT THE PUMP CONFIRMED THE REPORTED TORN AND LIFTED DOWNSTREAM OCCLUSION (DSO) SEAL. THERE WERE NO PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532377 ↗
• MalfunctionMar 5, 2026Device Sensing Problem

  IT WAS REPORTED THAT, DURING TESTING, THE DEVICE WAS REPORTED TO HAVE A ¿CASSETTE NOT ATTACHED¿ ERROR. EVALUATION OF THE RETURNED DEVICE IDENTIFIED A FAULTY DOWNSTREAM OCCLUSION SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524758 ↗
• MalfunctionFeb 12, 2026Failure to Sense

  IT WAS REPORTED THAT THE PUMP WAS SHOWING CASSETTE NOT ATTACHED ERROR. THE EVENT OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326955 ↗
• MalfunctionFeb 10, 2026Break

  THE CUSTOMER STATED THAT THE DEVICE HAD BROKEN BATTERY LATCH. NOT RELATED TO PHYSICAL DAMAGE/ABUSE. THE EVENT OCCURRED DURING TESTING. IT WAS STATED THAT THE DEVICE WAS REPORTED TO HAVE A DAMAGED BATTERY COMPARTMENT AND A SCRATCHED LENS. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. EVALUATION OF THE RETURNED DEVICE WAS CONFIRMED THE REPORTED ISSUE, AND THE CAUSE OF THE ISSUE WAS LATCH LOCK FLEX STRIP SENSOR. IT MAY CAUSE A LOSS OF POWER AND FAILURE TO DELIVER MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304805 ↗
• MalfunctionFeb 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE AIR SENSOR AND DOWNSTREAM OCCLUSION (DSO) SEAL ARE UNATTACHED AND FALLING OFF. THE EVENT OCCURRED DURING TESTING. THERE WERE NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279979 ↗
• MalfunctionDec 31, 2025Failure to Charge; Failure to Infuse; Failure to Charge; Failure to Infuse

  THE CUSTOMER RETURNED THE PRODUCT FOR ERROR CODE 41786, ACCOMPANIED BY A CONSTANT ALARM. THE DEVICE REQUIRES A SOFTWARE UPDATE TO VERSION 1.6 AND FURTHER EVALUATION AND REPAIR BY ICU. DURING DEVICE ANALYSIS, THE ERROR CODE 41786 WAS CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934508 ↗
• MalfunctionDec 22, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE DEVICE FAILED VOLUME TEST TWICE. BOTH TIMES MEASURED 17.1 FOR A 20 ML DOSE. THE EVENT OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863527 ↗
• MalfunctionNov 17, 2025Dent in Material; Dent in Material

  THE CUSTOMER RETURNED THE PRODUCT FOR DAMAGED BATTERY COVER, AND THE MOTOR REQUIRED SERVICING, DURING DEVICE ANALYSIS, A BUCKLING UPSTREAM OCCLUSION (USO) SEAL WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575521 ↗
• MalfunctionNov 10, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PUMP EXHIBITED A CASSETTE NOT ATTACHED PROPERLY ALARM. ALARM DID NOT CLEAR WHEN THE CASSETTE WAS ATTACHED. 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 23514113 ↗
• MalfunctionNov 7, 2025Material Separation; Material Separation

  THE CUSTOMER RETURNED THE PRODUCT FOR CASSETTE NOT ATTACHED ERROR, DURING DEVICE ANALYSIS, A LIFTING DOWNSTREAM OCCLUSION (DSO) SENSOR WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498470 ↗
• MalfunctionNov 6, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT WHEN RUNNING, AFTER THE FIRST ACTIVATION, THE DEVICE GAVE THE ERROR CODE 41622 AND PLAYED THE BATTERY FALLOUT ALARM. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486493 ↗
• MalfunctionAug 19, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE HAD ALARMED, DISPLAYING A RED SCREEN WITH WARNING TRIANGLES AND THE NUMBER "46876." NO PATIENT HARM HAD OCCURRED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838901 ↗
• MalfunctionAug 7, 2025Mechanical Problem; Mechanical Problem

  THE CUSTOMER RETURNED THE PRODUCT FOR SCREEN WAS BLACK WHEN THE PUMP POWERS UP, DURING DEVICE ANALYSIS, IT WAS FOUND THAT THE DOWNSTREAM OCCLUSION (DSO) SENSOR WAS DEFECTIVE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737372 ↗
• MalfunctionJul 28, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS DAMAGED. EVALUATION OF THE RETURNED DEVICE FOUND DAMAGE TO THE LATCH LOCK SENSOR AND UPSTREAM OCCLUSION SENSOR, AND THE UPSTREAM OCCLUSION SEAL WAS BUCKLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636755 ↗

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-0222-2025 · Jul 16, 2024 · Open, Classified
  CADD-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, Classified
  smiths 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 · Terminated
  CADD-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