CADD 21-2120-0102-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 381 adverse event reports that list this exact device (DI 10610586042591), received between Jun 27, 2023 and Sep 16, 2026 — classified as 381 malfunctions.

The most frequently reported specific device problem is “Degraded” (64 reports).

3 FDA recall records name this device's identifier, 3 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. 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. 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 381 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Inaccurate Delivery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50795957 ↗
• MalfunctionSep 16, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793338 ↗
• MalfunctionAug 31, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50527894 ↗
• MalfunctionAug 26, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461952 ↗
• MalfunctionAug 13, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241113 ↗
• MalfunctionJul 27, 2026Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024512 ↗
• MalfunctionJun 25, 2026Failure to Infuse

  THE CUSTOMER RETURNED THE DEVICE STATING, "DEVICE IS FOR REPAIR". DURING DEVICE EVALUATION IT WAS FOUND LEC 44509. THIS IS A HIGH-PRIORITY ERROR INDICATING A CRITICAL CONDITION WHICH MAY RESULT IN AN INTERRUPTION OF THERAPY. THERE WAS NO PATIENT INVOLVED AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627932 ↗
• MalfunctionJun 22, 2026Failure to Infuse; Obstruction of Flow

  IT WAS STATED THAT PUMP TRIGGERED REPEATED DOWNSTREAM OCCLUSION ALARM. THE HIGH-PRIORITY ALARM OCCURRED BEFORE PATIENT USE. HOWEVER, IF THE ISSUE REOCCURS DURING INFUSION, IT WILL INTERRUPT THERAPY AND POTENTIALLY AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25585695 ↗
• MalfunctionMay 21, 2026Crack

  IT WAS REPORTED THAT AN INFUSION PUMP HAD A CRACKED DOWNSTREAM OCCLUSION SENSOR (DSO) SEAL. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED AS THE EVENT WAS NOTED DURING PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246713 ↗
• MalfunctionMay 12, 2026Device Sensing Problem; Material Integrity Problem

  AN EVENT INVOLVING A CADD PUMP REPORTED THAT THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS FOUND OPEN DURING PRE-TESTING, WHICH COULD RESULT IN IMPROPER OCCLUSION DETECTION AND ALLOW FLUID TO ENTER THE PUMP, POTENTIALLY LEADING TO THERAPY INTERRUPTION. ADDITIONALLY, THE PUMP HAD A DIM LCD SCREEN AND A CRACKED BATTERY COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149049 ↗
• MalfunctionMay 12, 2026Detachment of Device or Device Component; Device Sensing Problem

  AN EVENT INVOLVING A CADD PUMP REPORTED THAT THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS FOUND OPEN DURING PRE-TESTING, WHICH COULD RESULT IN IMPROPER OCCLUSION DETECTION AND ALLOW FLUID TO ENTER THE PUMP, POTENTIALLY LEADING TO THERAPY INTERRUPTION. ADDITIONALLY, PUMP DISPLAYED AN ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149009 ↗
• MalfunctionMay 12, 2026Degraded; Improper Flow or Infusion

  IT WAS REPORTED THAT THE PUMP HAD A MOTOR SERVICE DUE AND A DOWNSTREAM OCCLUSION SEAL OPEN. REPORTER ALSO ALLEGED ERROR CODE 46440 WAS BEEPING. THE EVENT OCCURRED DURING PRE-TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148891 ↗
• MalfunctionMay 12, 2026Degraded

  IT WAS REPORTED THAT THE PUMP HAD A MOTOR SERVICE DUE AND A DOWNSTREAM OCCLUSION (DSO) SEAL OPEN. THE EVENT OCCURRED DURING PRE-TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148790 ↗
• MalfunctionMay 12, 2026Degraded

  IT WAS REPORTED THAT THE PUMP HAD A MOTOR SERVICE DUE AND A DOWNSTREAM OCCLUSION (DSO) SEAL OPEN. THE EVENT OCCURRED DURING PRE-TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148788 ↗
• MalfunctionMay 5, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD DISPLAYED RED SCREEN WITH AN ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081454 ↗
• MalfunctionApr 27, 2026Device Sensing Problem

  AN EVENT INVOLVED A CADD-SOLIS VIP AMBULATORY INFUSION PUMP REPORTED THAT THE PUMP DOES NOT DETECT THE CASSETTE ANYMORE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998768 ↗
• MalfunctionApr 15, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP HAD AN EVENT OF ALARM: CASSETTE IMPROPERLY INSTALLED. REINSTALL THE CASSETTE. WHICH HAPPENED REGARDLESS OF THE CASSETTE INSTALLED PROPERLY. THE ALARM SOMETIMES REMAINS ACTIVE EVEN AFTER REMOVING THE CASSETTE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885058 ↗
• MalfunctionApr 8, 2026Failure to Sense

  IT WAS REPORTED THAT THE PUMP REPEATEDLY INDICATED THE CASSETTE WAS NOT ATTACHED PROPERLY AND WAS REATTACHED. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818775 ↗
• MalfunctionMar 18, 2026Excessive Heating

  IT WAS REPORTED THAT UNIT OVERHEATED DURING PATIENT ADMINISTRATION. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631809 ↗
• MalfunctionMar 18, 2026Failure to Infuse

  THE DEVICE WAS RETURNED AS IT WAS REPORTED THAT THERE WAS AN ERROR CODE FAILURE 42224 SYSTEM DURING POWER UP. THE RESULTS OF THE INVESTIGATION CONFIRMED THE REPORTED ISSUE IN THE DEVICE'S HISTORY LOG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629824 ↗
• MalfunctionMar 13, 2026Calibration Problem

  IT WAS REPORTED THAT THE FLOW RATE IS OUT OF TOLERANCE. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597391 ↗
• MalfunctionMar 12, 2026Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE EXHIBITED ERROR CODE 46507. THE TIME DOES NOT INCREMENT WHEN THE DEVICE IS CLOSED (BATTERY FOR THE INTERNAL CLOCK NEEDS REPLACING). THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581067 ↗
• MalfunctionMar 11, 2026Failure to Infuse

  THE CUSTOMER RETURNED THE PRODUCT FOR ERROR CODE 45169 AND ALARMING. WATER/LIQUID (DISPLAY LCD) DEFECTIVE, MISSING INSULATORS POGO PIN. DURING DEVICE EVALUATION, ERROR CODE 44000 AND A RED SCREEN WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569077 ↗
• MalfunctionMar 9, 2026Failure to Infuse; Device Sensing Problem

  IT WAS FOUND DURING THE INVESTIGATION OF A RETURNED PUMP THAT ALARM FALL OUT LATCH WON'T TOGGLE ERROR WAS REPLICATED UPON POWERING THE DEVICE. ADDITIONALLY, WATER SPILLS OBSERVED ON LCD DISPLAY DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550657 ↗
• MalfunctionFeb 18, 2026Defective Alarm; Complete Blockage; Defective Component

  IT WAS STATED THAT THE DEVICE WAS BEEPING IN OCCLUSION WITH NO REASON AND THE CUSTOMER HAD TO REMOVE THE BATTERY TO TURN IT OFF. DURING INVESTIGATION FOUND THE FOUND DAMAGED DSO SEAL. THIS MALFUNCTION MAKES THE EVENT REPORTABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383192 ↗

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-1682-2025 · Apr 10, 2025 · Open, Classified
  CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP
• 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